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Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes (VITAL-2)

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WW Intervention
Usual Care
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18.0 - 74.9 years of age Participant-reported diagnosis of type 2 diabetes HbA1c 7.0%-11% (inclusive) Overweight or obesity (BMI 25-50 kg/m2) On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted) Willingness to attend weekly WW Virtual Workshops and participate in WW Digital program Access to a smartphone/tablet that can download the WW app Willing and able to provide a valid email address for use in the study Be able to communicate (oral and written) in English Be under the care of a physician who will be responsible for managing the subject's diabetes and a participant who is willing to give release to provide their treating MD with information about the trial Be able to provide informed consent Exclusion Criteria: Participation in a weight control program within the past 3 months Weight loss of ≥ 5 kg in the previous 6 months Taking prescription or over-the-counter weight loss medications within last 3 months History of weight loss surgery History of major surgery within three months of enrollment Type 1 diabetes Renal insufficiency consisting of potassium over 5.5 mmol/L on a non-hemolyzed specimen, or a creatinine > 2.5 mg/dL Albumin < 3 g/dL Alanine Aminotransferase > 3 times the upper limit of normal (normal range is 7-56 IU/L) More than 1 severe hypoglycemic event (requiring emergency medical services) in the past 12 months, unless the participant's physician provides written clearance for participation Hemoglobinopathy that interferes with measurement of HbA1c Class II or higher congestive heart failure Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia) Presence of implanted cardiac defibrillator Blood pressure ≥160/100 mm Hg. If a potential participant has a blood pressure ≥160/100 mm Hg it is acceptable to re-test this potential participant within one week of the original test Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 2 months is acceptable Orthopedic limitations that would interfere with ability to engage in regular physical activity Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year) History of clinically diagnosed eating disorder including anorexia nervosa or bulimia nervosa. Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per day during study participation Participation in another clinical trial within 30 days prior to enrollment Participation in WW anytime since November 2021 Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial

Sites / Locations

  • Pennington Biomedical Research Center
  • Wake Forest University Health Sciences
  • University of Pittsburgh Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WW Intervention

Usual Care

Arm Description

Participants in the intervention arm will be contacted by a WW Coach and will receive a voucher code that provides 12 months of access to the WW program and instructions for redeeming the code. The program will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes.

Patients in the Usual Care Arm will continue to receive routine medical care by their healthcare provider. In addition, at the baseline visit, participants in the Usual Care Arm will receive one 50-minute virtual on-line session of nutrition counseling with a registered dietitian, with additional materials at the time of their 6- and 12-month follow-up assessments, based on current recommendations of the American Diabetes Association

Outcomes

Primary Outcome Measures

Change in HbA1c% at 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Change in HbA1c% at 12 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods

Secondary Outcome Measures

Percent weight loss at 6 months
Body weight is measured using standard methods with the patient wearing light clothing
Percent weight loss at 12 months
Body weight is measured using standard methods with the patient wearing light clothing
Change in waist circumference at 6 months
Waist circumference is measured using standard methods with an inelastic tape
Change in waist circumference at 12 months
Waist circumference is measured using standard methods with an inelastic tape
Change in systolic blood pressure at 6 months
Systolic blood pressure is measured using standard clinical methods
Change in systolic blood pressure at 12 months
Systolic blood pressure is measured using standard clinical methods
Change in diastolic blood pressure at 6 months
Diastolic blood pressure is measured using standard clinical methods
Change in diastolic blood pressure at 12 months
Diastolic blood pressure is measured using standard clinical methods
Change in total cholesterol at 6 months
Total cholesterol is assayed using standard laboratory methods
Change in total cholesterol at 12 months
Total cholesterol is assayed using standard laboratory methods
Change in high-density lipoprotein cholesterol at 6 months
High-density lipoprotein cholesterol is assayed using standard laboratory methods
Change in high-density lipoprotein cholesterol at 12 months
High-density lipoprotein cholesterol is assayed using standard laboratory methods
Change in low-density lipoprotein cholesterol at 6 months
Low-density lipoprotein cholesterol is estimated using standard laboratory methods
Change in low-density lipoprotein cholesterol at 12 months
Low-density lipoprotein cholesterol is estimated using standard laboratory methods
Change in triglycerides at 6 months
Triglycerides are assayed using standard laboratory methods
Change in triglycerides at 12 months
Triglycerides are assayed using standard laboratory methods
Change in physical activity at 6 months
Physical activity is assessed with the Global Physical Activity Questionnaire. A valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions.
Change in physical activity at 12 months
Physical activity is assessed with the Global Physical Activity Questionnaire. A valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions.
Change in dietary intake at 6 months
Dietary Intake will be assessed using DietID (www.DietID.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient intake data and a Healthy Eating Index 2015 score.
Change in dietary intake at 12 months
Dietary Intake will be assessed using DietID (www.DietID.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient intake data and a Healthy Eating Index 2015 score.
Change in perceived stress at 6 months
Perceived stress is measured using the Perceived Stress Scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress.
Change in perceived stress at 12 months
Perceived stress is measured using the Perceived Stress Scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress.
Change in diabetes distress at 6 months
The Diabetes Distress Scale contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Change in diabetes distress at 12 months
The Diabetes Distress Scale contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Change in quality of life at 6 months
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life. Respondents rate the degree to which their weight affects them on 31 items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4, usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function, self-esteem, sexual life, public distress, and work).
Change in quality of life at 12 months
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life. Respondents rate the degree to which their weight affects them on 31 items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4, usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function, self-esteem, sexual life, public distress, and work).
Change in well-being at 6 months
Well-being will be measured using the World Health Organization-5 Well-being Index, which consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale (0, at no time; 1, some of the time; 2, less than half of the time; 3, more than half of the time; 4, most of the time; 5, all of the time). The total raw score ranges from 0 to 25, and is multiplied by 4 to give the final score, with 0 representing the worse imaginable well-being and 100 representing the best imaginable well-being.
Change in well-being at 12 months
Well-being will be measured using the World Health Organization-5 Well-being Index, which consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale (0, at no time; 1, some of the time; 2, less than half of the time; 3, more than half of the time; 4, most of the time; 5, all of the time). The total raw score ranges from 0 to 25, and is multiplied by 4 to give the final score, with 0 representing the worse imaginable well-being and 100 representing the best imaginable well-being.
Change in habit strength at 6 months
Habit strength will be assessed with the Self-Report Behavioral Automaticity Index, a 4-item measure that that is reliable, correlates highly with existing measures, and is sensitive to effects that characterize habits. The 4-items assess whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree.
Change in habit strength at 12 months
Habit strength will be assessed with the Self-Report Behavioral Automaticity Index, a 4-item measure that that is reliable, correlates highly with existing measures, and is sensitive to effects that characterize habits. The 4-items assess whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree.
Change in emotional eating at 6 months
Emotional eating will be measured with the Palatable Eating Motives Scale- Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always.
Change in emotional eating at 12 months
Emotional eating will be measured with the Palatable Eating Motives Scale- Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always.
Change in hunger at 6 months
Hunger will be measured using the Hunger Visual Analogue Scale, which is a reliable measure for appetite research. The Hunger Visual Analogue Scale asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.
Change in hunger at 12 months
Hunger will be measured using the Hunger Visual Analogue Scale, which is a reliable measure for appetite research. The Hunger Visual Analogue Scale asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.
Change in diabetes medications at 6 months
The number of diabetes medications is summed at each time point
Change in diabetes medications at 12 months
The number of diabetes medications is summed at each time point
Change in proportion of patents achieving an HbA1c% <=6.5% at 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Change in proportion of patents achieving an HbA1c% <=6.5% at 12 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Change in proportion of patents achieving an HbA1c% <=7% at 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Change in proportion of patents achieving an HbA1c% <=7% at 12 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Change in food cravings at 6 months
Food cravings will be assessed using the Food Cravings Inventory, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, & fruits and vegetables. The questionnaire is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, & Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. FCI-Fr/Veg=Average of items 5,12,18,21,29. Total=Average of all 33 items.
Change in food cravings at 12 months
Food cravings will be assessed using the Food Cravings Inventory, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, & fruits and vegetables. The questionnaire is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, & Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. FCI-Fr/Veg=Average of items 5,12,18,21,29. Total=Average of all 33 items.
Change in self compassion at 6 months
Self-compassion will be assessed using the Self-Compassion Scale, a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The scale consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means.
Change in self compassion at 12 months
Self-compassion will be assessed using the Self-Compassion Scale, a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The scale consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means.
Change in restraint/disinhibition at 6 months
The Three Factor Eating Questionnaire- Restraint and Disinhibition subscales measures cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate greater levels of restraint or disinhibition.
Change in restraint/disinhibition at 12 months
The Three Factor Eating Questionnaire- Restraint and Disinhibition subscales measures cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate greater levels of restraint or disinhibition.
Change in body appreciation at 6 months
The Body Appreciation Scale measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always.
Change in body appreciation at 12 months
The Body Appreciation Scale measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always.
Change in weight bias at 6 months
The Weight Bias Internalization Scale has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average.
Change in weight bias at 12 months
The Weight Bias Internalization Scale has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average.

Full Information

First Posted
December 15, 2022
Last Updated
January 18, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
Weight Watchers International
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1. Study Identification

Unique Protocol Identification Number
NCT05663554
Brief Title
Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
Acronym
VITAL-2
Official Title
Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study sponsor cancelled funding prior to enrolment due to competing priorities.
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Weight Watchers International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a randomized clinical trial with the primary aim of determining the effectiveness of the WW intervention at reducing HbA1c in patients with type 2 diabetes.
Detailed Description
This study is a 12-month, two-arm, parallel controlled trial. Up to 486 adults with overweight or obesity and type 2 diabetes will be randomized to either 1) intervention or 2) usual care. The intervention arm will participate in a WW program which will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes. Participants in the usual care arm will receive their normal, usual care from their healthcare providers in addition to a session with a Registered Dietician at baseline. All patients will participate in the collection of patient-reported outcomes at baseline and at 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WW Intervention
Arm Type
Experimental
Arm Description
Participants in the intervention arm will be contacted by a WW Coach and will receive a voucher code that provides 12 months of access to the WW program and instructions for redeeming the code. The program will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients in the Usual Care Arm will continue to receive routine medical care by their healthcare provider. In addition, at the baseline visit, participants in the Usual Care Arm will receive one 50-minute virtual on-line session of nutrition counseling with a registered dietitian, with additional materials at the time of their 6- and 12-month follow-up assessments, based on current recommendations of the American Diabetes Association
Intervention Type
Behavioral
Intervention Name(s)
WW Intervention
Intervention Description
The core of the WW food program is the SmartPoints® system. Briefly, the SmartPoints® system assigns each food and beverage a SmartPoints® value per volume based on four components: calories, sugar, saturated fat, and protein. Certain foods have a SmartPoints® value of zero (ZeroPoint foods). These foods (e.g., lean sources of protein such as skinless chicken breast and vegetables) form the basis of a healthy eating pattern, are at low risk for overconsumption and do not have to be weighed, measured or tracked. Participants were assigned a personalized SmartPoints® Budget, based on reported food and lifestyle preferences, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
The Usual Care group will continue to receive routine medical care by their provider, in addition to receiving one 50-minute virtual on-line session of nutrition counseling with a registered dietitian, with additional materials at the time of their 6- and 12-month follow-up assessments.
Primary Outcome Measure Information:
Title
Change in HbA1c% at 6 months
Description
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time Frame
Baseline and 6 months.
Title
Change in HbA1c% at 12 months
Description
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time Frame
Baseline and 12 months.
Secondary Outcome Measure Information:
Title
Percent weight loss at 6 months
Description
Body weight is measured using standard methods with the patient wearing light clothing
Time Frame
Baseline and 6 months
Title
Percent weight loss at 12 months
Description
Body weight is measured using standard methods with the patient wearing light clothing
Time Frame
Baseline and 12 months
Title
Change in waist circumference at 6 months
Description
Waist circumference is measured using standard methods with an inelastic tape
Time Frame
Baseline and 6 months
Title
Change in waist circumference at 12 months
Description
Waist circumference is measured using standard methods with an inelastic tape
Time Frame
Baseline and 12 months
Title
Change in systolic blood pressure at 6 months
Description
Systolic blood pressure is measured using standard clinical methods
Time Frame
Baseline and 6 months
Title
Change in systolic blood pressure at 12 months
Description
Systolic blood pressure is measured using standard clinical methods
Time Frame
Baseline and 12 months
Title
Change in diastolic blood pressure at 6 months
Description
Diastolic blood pressure is measured using standard clinical methods
Time Frame
Baseline and 6 months
Title
Change in diastolic blood pressure at 12 months
Description
Diastolic blood pressure is measured using standard clinical methods
Time Frame
Baseline and 12 months
Title
Change in total cholesterol at 6 months
Description
Total cholesterol is assayed using standard laboratory methods
Time Frame
Baseline and 6 months
Title
Change in total cholesterol at 12 months
Description
Total cholesterol is assayed using standard laboratory methods
Time Frame
Baseline and 12 months
Title
Change in high-density lipoprotein cholesterol at 6 months
Description
High-density lipoprotein cholesterol is assayed using standard laboratory methods
Time Frame
Baseline and 6 months
Title
Change in high-density lipoprotein cholesterol at 12 months
Description
High-density lipoprotein cholesterol is assayed using standard laboratory methods
Time Frame
Baseline and 12 months
Title
Change in low-density lipoprotein cholesterol at 6 months
Description
Low-density lipoprotein cholesterol is estimated using standard laboratory methods
Time Frame
Baseline and 6 months
Title
Change in low-density lipoprotein cholesterol at 12 months
Description
Low-density lipoprotein cholesterol is estimated using standard laboratory methods
Time Frame
Baseline and 12 months
Title
Change in triglycerides at 6 months
Description
Triglycerides are assayed using standard laboratory methods
Time Frame
Baseline and 6 months
Title
Change in triglycerides at 12 months
Description
Triglycerides are assayed using standard laboratory methods
Time Frame
Baseline and 12 months
Title
Change in physical activity at 6 months
Description
Physical activity is assessed with the Global Physical Activity Questionnaire. A valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions.
Time Frame
Baseline and 6 months
Title
Change in physical activity at 12 months
Description
Physical activity is assessed with the Global Physical Activity Questionnaire. A valid and reliable instrument from the World Health Organization that measures physical activity intensity, duration, and frequency in three domains: occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time. It also captures sedentary time. There are 16 questions.
Time Frame
Baseline and 12 months
Title
Change in dietary intake at 6 months
Description
Dietary Intake will be assessed using DietID (www.DietID.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient intake data and a Healthy Eating Index 2015 score.
Time Frame
Baseline and 6 months
Title
Change in dietary intake at 12 months
Description
Dietary Intake will be assessed using DietID (www.DietID.com). DietID harnesses diet quality photo navigation technology to identify participant's dietary intake by showing a series of images that participants select based on what reflects their current dietary pattern. Once a pattern is identified, DietID provides nutrient intake data and a Healthy Eating Index 2015 score.
Time Frame
Baseline and 12 months
Title
Change in perceived stress at 6 months
Description
Perceived stress is measured using the Perceived Stress Scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress.
Time Frame
Baseline and 6 months
Title
Change in perceived stress at 12 months
Description
Perceived stress is measured using the Perceived Stress Scale, a 10-item questionnaire that measures the extent to which a participant's life is unpredictable, uncontrollable, and overloading. It was designed for use in older adolescents and adults, and is considered to have adequate internal reliability and construct validity. Each question asks about how the participant has felt or thought in the past month and uses a 5-point Likert scale (0=never, 4=very often). Scores are calculated by summing responses and higher scores indicate greater perceived stress.
Time Frame
Baseline and 12 months
Title
Change in diabetes distress at 6 months
Description
The Diabetes Distress Scale contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Time Frame
Baseline and 6 months
Title
Change in diabetes distress at 12 months
Description
The Diabetes Distress Scale contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Time Frame
Baseline and 12 months
Title
Change in quality of life at 6 months
Description
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life. Respondents rate the degree to which their weight affects them on 31 items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4, usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function, self-esteem, sexual life, public distress, and work).
Time Frame
Baseline and 6 months
Title
Change in quality of life at 12 months
Description
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life. Respondents rate the degree to which their weight affects them on 31 items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4, usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function, self-esteem, sexual life, public distress, and work).
Time Frame
Baseline and 12 months
Title
Change in well-being at 6 months
Description
Well-being will be measured using the World Health Organization-5 Well-being Index, which consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale (0, at no time; 1, some of the time; 2, less than half of the time; 3, more than half of the time; 4, most of the time; 5, all of the time). The total raw score ranges from 0 to 25, and is multiplied by 4 to give the final score, with 0 representing the worse imaginable well-being and 100 representing the best imaginable well-being.
Time Frame
Baseline and 6 months
Title
Change in well-being at 12 months
Description
Well-being will be measured using the World Health Organization-5 Well-being Index, which consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale (0, at no time; 1, some of the time; 2, less than half of the time; 3, more than half of the time; 4, most of the time; 5, all of the time). The total raw score ranges from 0 to 25, and is multiplied by 4 to give the final score, with 0 representing the worse imaginable well-being and 100 representing the best imaginable well-being.
Time Frame
Baseline and 12 months
Title
Change in habit strength at 6 months
Description
Habit strength will be assessed with the Self-Report Behavioral Automaticity Index, a 4-item measure that that is reliable, correlates highly with existing measures, and is sensitive to effects that characterize habits. The 4-items assess whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree.
Time Frame
Baseline and 6 months
Title
Change in habit strength at 12 months
Description
Habit strength will be assessed with the Self-Report Behavioral Automaticity Index, a 4-item measure that that is reliable, correlates highly with existing measures, and is sensitive to effects that characterize habits. The 4-items assess whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree.
Time Frame
Baseline and 12 months
Title
Change in emotional eating at 6 months
Description
Emotional eating will be measured with the Palatable Eating Motives Scale- Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always.
Time Frame
Baseline and 6 months
Title
Change in emotional eating at 12 months
Description
Emotional eating will be measured with the Palatable Eating Motives Scale- Coping Subscale, which measures intentionally using palatable food to cope with negative feelings and has demonstrated reliability, convergent validity and discriminant validity. The coping subscale additionally demonstrated incremental validity with BMI. The coping subscale consists of 4 questions with response options Almost Never/Never to Almost always/Always.
Time Frame
Baseline and 12 months
Title
Change in hunger at 6 months
Description
Hunger will be measured using the Hunger Visual Analogue Scale, which is a reliable measure for appetite research. The Hunger Visual Analogue Scale asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.
Time Frame
Baseline and 6 months
Title
Change in hunger at 12 months
Description
Hunger will be measured using the Hunger Visual Analogue Scale, which is a reliable measure for appetite research. The Hunger Visual Analogue Scale asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.
Time Frame
Baseline and 12 months
Title
Change in diabetes medications at 6 months
Description
The number of diabetes medications is summed at each time point
Time Frame
Baseline and 6 months
Title
Change in diabetes medications at 12 months
Description
The number of diabetes medications is summed at each time point
Time Frame
Baseline and 12 months
Title
Change in proportion of patents achieving an HbA1c% <=6.5% at 6 months
Description
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time Frame
Baseline and 6 months
Title
Change in proportion of patents achieving an HbA1c% <=6.5% at 12 months
Description
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time Frame
Baseline and 12 months
Title
Change in proportion of patents achieving an HbA1c% <=7% at 6 months
Description
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time Frame
Baseline and 6 months
Title
Change in proportion of patents achieving an HbA1c% <=7% at 12 months
Description
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Time Frame
Baseline and 12 months
Title
Change in food cravings at 6 months
Description
Food cravings will be assessed using the Food Cravings Inventory, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, & fruits and vegetables. The questionnaire is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, & Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. FCI-Fr/Veg=Average of items 5,12,18,21,29. Total=Average of all 33 items.
Time Frame
Baseline and 6 months
Title
Change in food cravings at 12 months
Description
Food cravings will be assessed using the Food Cravings Inventory, a 33-item self-report measure designed to assess the subjective experience of food craving across 33 different foods. The measure consists of 5 empirically-derived factors: high fats, sweets, carbohydrates, starches, fast food fats, & fruits and vegetables. The questionnaire is scaled in a frequency format, assessing the frequency with which an individual experiences a craving for a particular food. All items are scored in the following manner: Never = 1, Rarely = 2, Sometimes = 3, Often = 4, & Always=5. Fat = Average of items 3,4,7,11,17,23,31,32. Sweet=Average of items 1,9,15,19,20,27,28,30. Carb=Average of items 6,10,14,16,22,25,26,33. FFF=Average of items 2,8,13,24. FCI-Fr/Veg=Average of items 5,12,18,21,29. Total=Average of all 33 items.
Time Frame
Baseline and 12 months
Title
Change in self compassion at 6 months
Description
Self-compassion will be assessed using the Self-Compassion Scale, a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The scale consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means.
Time Frame
Baseline and 6 months
Title
Change in self compassion at 12 months
Description
Self-compassion will be assessed using the Self-Compassion Scale, a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The scale consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means.
Time Frame
Baseline and 12 months
Title
Change in restraint/disinhibition at 6 months
Description
The Three Factor Eating Questionnaire- Restraint and Disinhibition subscales measures cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate greater levels of restraint or disinhibition.
Time Frame
Baseline and 6 months
Title
Change in restraint/disinhibition at 12 months
Description
The Three Factor Eating Questionnaire- Restraint and Disinhibition subscales measures cognitive restraint of eating and disinhibition. The scales contain 37 items and have been tested for reliability and validity. Higher scores indicate greater levels of restraint or disinhibition.
Time Frame
Baseline and 12 months
Title
Change in body appreciation at 6 months
Description
The Body Appreciation Scale measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always.
Time Frame
Baseline and 6 months
Title
Change in body appreciation at 12 months
Description
The Body Appreciation Scale measures individuals acceptance of, favorable opinions toward, and respect for their bodies. The scale demonstrates internal consistency, convergent validity, incremental validity, and discriminant validity. Measurement invariance upheld across sexes and US sample types (college vs. community samples). There are 10 items, each assessed on a scale from 1-never to 5-always.
Time Frame
Baseline and 12 months
Title
Change in weight bias at 6 months
Description
The Weight Bias Internalization Scale has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average.
Time Frame
Baseline and 6 months
Title
Change in weight bias at 12 months
Description
The Weight Bias Internalization Scale has 13 items and responses are rated on a 7-point Likert scale (strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The scale has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18.0 - 74.9 years of age Participant-reported diagnosis of type 2 diabetes HbA1c 7.0%-11% (inclusive) Overweight or obesity (BMI 25-50 kg/m2) On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted) Willingness to attend weekly WW Virtual Workshops and participate in WW Digital program Access to a smartphone/tablet that can download the WW app Willing and able to provide a valid email address for use in the study Be able to communicate (oral and written) in English Be under the care of a physician who will be responsible for managing the subject's diabetes and a participant who is willing to give release to provide their treating MD with information about the trial Be able to provide informed consent Exclusion Criteria: Participation in a weight control program within the past 3 months Weight loss of ≥ 5 kg in the previous 6 months Taking prescription or over-the-counter weight loss medications within last 3 months History of weight loss surgery History of major surgery within three months of enrollment Type 1 diabetes Renal insufficiency consisting of potassium over 5.5 mmol/L on a non-hemolyzed specimen, or a creatinine > 2.5 mg/dL Albumin < 3 g/dL Alanine Aminotransferase > 3 times the upper limit of normal (normal range is 7-56 IU/L) More than 1 severe hypoglycemic event (requiring emergency medical services) in the past 12 months, unless the participant's physician provides written clearance for participation Hemoglobinopathy that interferes with measurement of HbA1c Class II or higher congestive heart failure Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia) Presence of implanted cardiac defibrillator Blood pressure ≥160/100 mm Hg. If a potential participant has a blood pressure ≥160/100 mm Hg it is acceptable to re-test this potential participant within one week of the original test Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 2 months is acceptable Orthopedic limitations that would interfere with ability to engage in regular physical activity Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year) History of clinically diagnosed eating disorder including anorexia nervosa or bulimia nervosa. Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per day during study participation Participation in another clinical trial within 30 days prior to enrollment Participation in WW anytime since November 2021 Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter T Katzmarzyk, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica L Baskin, PhD
Organizational Affiliation
University of Pittsburgh Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamy D Ard, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Pittsburgh Health Sciences
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified individual-level dataset will be made available to researchers making a reasonable request to the principal investigator. Data will be made available 1 year after publication of the primary outcomes manuscript.
IPD Sharing Time Frame
Data and supporting information will be available 1 year after the publication of the primary outcome paper.
IPD Sharing Access Criteria
Upon reasonable request to the Principal Investigator.

Learn more about this trial

Improving Glycemic Control Using a Virtual Weight Control Program Among Adults With Type 2 Diabetes

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