Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Primary Purpose
Obesity, Weight Loss
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modified WW Food program
Sponsored by

About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Ages 18-75 years
- Body Mass Index (BMI) of 25 to 43
- Self-reported desire to lose weight
- Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
- Willing to follow recommendations required by study protocol
- Willing to include demographic information (e.g., ethnicity, income and education)
- Use of a personal iPhone on a daily basis
- Basic app skills
- Reliable home Wi-Fi access
- Ability to commit to attending up to 27 study visits in approximately 26 weeks
Exclusion Criteria
- Participants that are currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs) or a structured weight-loss program (e.g., at a medical center, university, commercial programs)
- Participants who were a member of WW within the past 12 months.
- Participants who are involved in any other research studies at this time (also, cannot join other research studies while in this study, over the next 6 months).
- Pregnant, nursing, or planning on becoming pregnant over the next 9 months.
- Weight loss of ≥ 5 kg in the previous 6 months.
- History of clinically diagnosed eating disorder.
- Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
- Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
- Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months
- Diuretic use, unless taken on a regular, daily basis for hypertension and on a stable dose for at least 30 days
- Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).
- History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
- Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
- Diagnosis of type 1 or type 2 diabetes
- Previous surgical procedure for weight loss.
- Major surgery within the previous 6 months.
- Presence of implanted cardiac defibrillator or pacemaker.
- History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
- Hospitalization for psychiatric disorders during the past 12 months
- Self-reported alcohol use > 7/week standard drinks for females and > 14/week for males or meets DSM-5 criteria for mild or greater, Alcohol Use Disorder
- Planning to relocate in the next 9 months
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified WW Food program
Arm Description
Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods.
Outcomes
Primary Outcome Measures
body weight change (kg)
average body weight change (kg) from baseline to six months
Secondary Outcome Measures
3-month change in weight (kg)
average 3-month change in weight (kg)
3-month change in weight, as a percentage of start weight
3-month change in weight, as a percentage of start weight
6-month changes in body weight as a percentage of start weight
6-month changes in body weight as a percentage of start weight
changes in Body Mass Index (BMI)
changes in Body Mass Index (BMI)
waist circumference
change in waist circumference as measured at natural waist with a non-stretch tape measure.
flexibility
change in flexibility as measured via standard sit-and-reach protocol
aerobic stamina
change in aerobic stamina as measured with the 6-minute walk test
blood pressure
change in blood pressure as measured by a blood pressure monitor
food cravings
change in reported food cravings as measured by the FCI-II
happiness
change in reported happiness as measured using the Oxford Happiness Questionnaire
sleep quality and duration: Pittsburgh Sleep Quality Index
change in sleep quality and duration as measured by the Pittsburgh Sleep Quality Index
weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)
change in reported weight related quality of life as measured by the Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)
subjective sensations of hunger
change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale
personal food assessment
changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire
program satisfaction: WW generated satisfaction questionnaire
program satisfaction as measured by the WW generated satisfaction questionnaire
health related quality of life: SF-36
changes in reported health related quality of life as measured through the SF-36
Full Information
NCT ID
NCT03928483
First Posted
April 23, 2019
Last Updated
December 10, 2019
Sponsor
Medical University of South Carolina
Collaborators
Weight Watchers International
1. Study Identification
Unique Protocol Identification Number
NCT03928483
Brief Title
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Official Title
Evaluation of a Commercial Program on Weight Loss and Health Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
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
To examine weight loss and acceptability of a modified WW program. This study is designed to detect differences in weight loss at the end of 24 weeks of intervention.
Detailed Description
This trial is an examination of a modified WW food program. The intention is to document the acceptability and efficacy of the dietary plan over 24 weeks. Subjects will participate in a program similar to WW Freestyle and have access to study-specific weekly workshops and a suite of study-specific digital tools for tracking eating, activity, and weight. Within a WW program, participants are provided instructions on calculating points for the foods and beverages they eat and drink. This study will examine the impact of the modified WW food program on weight and fitness levels of adults with overweight and obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This single-armed trial will have one condition: the modified WW Food program.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified WW Food program
Arm Type
Experimental
Arm Description
Participants will be assigned to a SmartPoints budget and number and types of ZeroPoint foods.
Intervention Type
Behavioral
Intervention Name(s)
Modified WW Food program
Intervention Description
Participants will receive a structured, holistic, behavioral weight management program that encourages development of healthy habits to help individuals eat healthier, move more, and shift to a more helpful mindset.
Primary Outcome Measure Information:
Title
body weight change (kg)
Description
average body weight change (kg) from baseline to six months
Time Frame
baseline to six months
Secondary Outcome Measure Information:
Title
3-month change in weight (kg)
Description
average 3-month change in weight (kg)
Time Frame
baseline to 3-months
Title
3-month change in weight, as a percentage of start weight
Description
3-month change in weight, as a percentage of start weight
Time Frame
baseline to 3-months
Title
6-month changes in body weight as a percentage of start weight
Description
6-month changes in body weight as a percentage of start weight
Time Frame
baseline to 6-months
Title
changes in Body Mass Index (BMI)
Description
changes in Body Mass Index (BMI)
Time Frame
baseline, 3-months and 6-months
Title
waist circumference
Description
change in waist circumference as measured at natural waist with a non-stretch tape measure.
Time Frame
baseline, 3-months and 6-months
Title
flexibility
Description
change in flexibility as measured via standard sit-and-reach protocol
Time Frame
baseline, 3-months and 6-months
Title
aerobic stamina
Description
change in aerobic stamina as measured with the 6-minute walk test
Time Frame
baseline, 3-months and 6-months
Title
blood pressure
Description
change in blood pressure as measured by a blood pressure monitor
Time Frame
baseline, 3-months and 6-months
Title
food cravings
Description
change in reported food cravings as measured by the FCI-II
Time Frame
baseline, 3-months and 6-months
Title
happiness
Description
change in reported happiness as measured using the Oxford Happiness Questionnaire
Time Frame
baseline, 3-months and 6-months
Title
sleep quality and duration: Pittsburgh Sleep Quality Index
Description
change in sleep quality and duration as measured by the Pittsburgh Sleep Quality Index
Time Frame
baseline, 3-months and 6-months
Title
weight related quality of life: Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)
Description
change in reported weight related quality of life as measured by the Impact of Weight Related Quality of Life- Lite (IWQOL-Lite)
Time Frame
baseline, 3-months and 6-months
Title
subjective sensations of hunger
Description
change in subjective sensations of hunger as measured by the Hunger Visual Analog Scale
Time Frame
baseline, 3-months and 6-months
Title
personal food assessment
Description
changes in reported personal food assessment as measured by the Block Food Frequency Questionnaire
Time Frame
baseline and 6-months
Title
program satisfaction: WW generated satisfaction questionnaire
Description
program satisfaction as measured by the WW generated satisfaction questionnaire
Time Frame
3-months and 6-months
Title
health related quality of life: SF-36
Description
changes in reported health related quality of life as measured through the SF-36
Time Frame
baseline, 3-months and 6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 18-75 years
Body Mass Index (BMI) of 25 to 43
Self-reported desire to lose weight
Willing to discontinue any current over-the-counter (OTC) supplements not recommended/prescribed by physician, with the exception of multivitamins or other vitamin supplement
Willing to follow recommendations required by study protocol
Willing to include demographic information (e.g., ethnicity, income and education)
Use of a personal iPhone on a daily basis
Basic app skills
Reliable home Wi-Fi access
Ability to commit to attending up to 27 study visits in approximately 26 weeks
Exclusion Criteria
Participants that are currently, or within the last 6 months, trying to lose weight by following guidelines (e.g., self-initiated programs) or a structured weight-loss program (e.g., at a medical center, university, commercial programs)
Participants who were a member of WW within the past 12 months.
Participants who are involved in any other research studies at this time (also, cannot join other research studies while in this study, over the next 6 months).
Pregnant, nursing, or planning on becoming pregnant over the next 9 months.
Weight loss of ≥ 5 kg in the previous 6 months.
History of clinically diagnosed eating disorder.
Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems)
Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months.
Taking any prescription medication with known effects on appetite or weight (e.g., oral steroids, weight loss medications such as Qysmia, Contrave, etc.) with the exception of subjects on a stable dose of SSRIs for 6 months
Diuretic use, unless taken on a regular, daily basis for hypertension and on a stable dose for at least 30 days
Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable).
History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months.
Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg
Diagnosis of type 1 or type 2 diabetes
Previous surgical procedure for weight loss.
Major surgery within the previous 6 months.
Presence of implanted cardiac defibrillator or pacemaker.
History of cancer within past 5 years or current treatment for cancer (completely resected basal or squamous cell carcinoma acceptable if treatment completed more than 6 months prior to enrollment).
Hospitalization for psychiatric disorders during the past 12 months
Self-reported alcohol use > 7/week standard drinks for females and > 14/week for males or meets DSM-5 criteria for mild or greater, Alcohol Use Disorder
Planning to relocate in the next 9 months
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of a Commercial Program on Weight Loss and Health Outcomes
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