Back to resultsVida Sana y Completa Obesity and Food Insecurity Study
Primary Purpose
Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vida Sana
Vida Sana y Completa
Sponsored by
About this trial
This is an interventional health services research trial for Obesity focused on measuring obesity, food insecurity, Latina, fitbit, Metabolic Diseases, Chronic Disease
Eligibility Criteria
Inclusion Criteria:
- Age: Lower age limit - 18 years, Upper age limit - NONE
- Race/ethnicity: self-reported Latinx ethnicity
- Sex: Female
- Body mass index: ≥ 30 kg/m2
- One or more metabolic risk factors as follows:
- Fasting plasma glucose of 100 to 125 mg/dL or HbA1c of 5.7 to 6.4 if detected by a recent (within the past year), documented, blood-based diagnostic test in the Electronic Health Record (EHR) in the last year
- Waist circumference >40 inches in men and >35 inches in women (≥35 inches in men and ≥31 inches in women, if of Asian descent) as measured by the study coordinator
- Triglycerides >150 mg/dL as documented in the EHR in the last year
- High-density lipoprotein cholesterol (HDL-C) <40 mg/dL in men and <50 mg/dL in women as documented in the EHR in the last year
- Systolic blood pressure >120 mmHg or diastolic blood pressure >80 mmHg as measured by study coordinator
- Food insecurity: Defined as answering yes to one or both questions of the Hunger Vital Sign
- PCP approval of patient contact for study screening
- Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of 2 study arms, participate for 24 months, and authorize extraction of relevant information from the EHR.
Exclusion Criteria:
- Previous diagnosis of diabetes (other than during pregnancy) or diabetes documented in the EHR
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years
Serious medical condition anticipated to prevent person from walking
1 mile (e.g., severe pulmonary disease or aortic stenosis)
- Severe medical comorbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
- Diagnosis of a terminal illness and/or in hospice care;
- Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
- Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
- Have had or plan to undergo bariatric surgery during the study period
Other exclusions:
- Inability to speak, read or understand Spanish
- Having no reliable telephone service
- Having no regular Internet access via a computer and/or mobile device (e.g., smartphone)
- Plan to move out of the area during the study period
- Planned pregnancy
- Family/household member of another study participant or of a study staff member
- Investigator discretion for clinical safety or protocol adherence reasons
Sites / Locations
- San Mateo Medical Center Fair Oaks Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Vida Sana
Vida Sana y Completa
Arm Description
Vida Sana is a cultural-adaption of Group Lifestyle Balance, a 12-month intervention that targets at least 5% weight loss and at least150 minutes per week of moderate-to-vigorous physical activity. Health coaches will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.
Vida Sana y Completa is an obesity intervention with integrated treatment for food insecurity. This arm includes all the activities described for the active comparator arm (Vida Sana) as well as a weekly food box delivery for the first 12 weeks of the intervention. The food box will contain approximately 40 pounds of food including proteins and dairy, whole grains, and produce. Just like the Vida Sana active comparator arm, the Vida Sana y Completa group will include health coaches who will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.
Outcomes
Primary Outcome Measures
Weight change (12 months)
Trained research assistants blinded to treatment assignment will weigh participants in duplicate using a standard calibrated scale at baseline, 12, and 24 months
Secondary Outcome Measures
Self-reported weight
Participants will self-report measures of weight at 6 and 18 months to the health coach via telephone.
Visit or EHR Height, Weight, and Waist Circumference
In person visits at baseline, 12-months and 24-months post enrollment will be used to collect participant weight, height and waist circumference. At baseline, these will be measured twice or in triplicate if there is a discrepancy. Height will be measured in centimeters, weight will be measured in kilograms, and waist circumference will be recorded in centimeters. If participants cannot be weighed in person for the primary outcome, weight measurement from the EHR if available within 3 months of the data collection date will be used.
Waist circumference will be measured according to standard protocols described by the National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual. http://www.cdc.gov/nchs/data/nhanes/nhanes_11_12/Anthropometry_Procedures_Manual.pdf. Published 2011.
Health-related quality of life
The validated SF-8™ will be used. It is a generic multipurpose short-form health-related quality of life instrument and was developed by the RAND Corporation and the Medical Outcomes Study (MOS) in the 1980s.
Obesity-specific quality of life
Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at baseline, 6 months, 12 months and at 24 months.
Change in Psychosocial Well-being: Depressive Symptoms
The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items plus a 10th question. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-points for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at baseline, 6 months, 12 months and at 24 months.
Cardiometabolic risk factors
Waist circumference will be measured at baseline, 12 months and at 24 months according to standard protocols described by the National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual. http://www.cdc.gov/nchs/data/nhanes/nhanes_11_12/Anthropometry_Procedures_Manual.pdf. Published 2011. Accessed October 29, 2014.
At baseline, 12 months and at 24 months blood pressure will be measured twice by a trained health coach, a third if there is a discrepancy. Blood pressure, fasting glucose, HbA1c, and lipids will be pulled from the medical record for each time point.
Participant Medication Usage
Participants will be asked to self-report medications/prescriptions. A list of prescribed medications will also be pulled from the electronic health record.
Dietary Intake Patterns
Dietary intake will be measured using the gold-standard approach of 3 multiple pass 24-hour recalls (2 during the weekday and 1 on the weekend at each time point). The Nutrition Data System for Research (NDSR), a validated approach, will be used. Changes in dietary intake over 24-months will be assessed.
Food Neophobia Scale
The Food Neophobia Scale (FNS) is a 10-item questionnaire that is comprised of likert type items ranging from "strongly disagree (1)" to "strongly agree (7)." Participants indicate their level of agreement for statements such as "I will eat almost anything" with higher scores indicating greater agreement per item.
Food Attitudes & Behaviors (FAB) Scale for self-efficacy
A subset of 7 items regarding Self-Efficacy to Eat Fruits and Vegetables will be used from the validated Food Attitudes & Behaviors (FAB) scale. These items are answered on a likert scale from "not at all confident" to "very confident" with an option for "does not apply." Scoring details are available on the NIH website (https://cancercontrol.cancer.gov/brp/hbrb/food-attitudes-and-behaviors).
Second Harvest of Silicon Valley Food Bank Self-Efficacy Measure
Two self-reported items from the Second Harvest of Silicon Valley food bank self-efficacy questionnaire will be asked. They are "In the past few months, have you tried a new recipe using food you received at a free food distribution?" and "And have you tried a new fruit or vegetable that you received at a free food distribution?" Answer choices are yes, no, or I did not receive food.
Participant self-reported 7-day Physical Activity Recall
The research team will administer the 7-day Physical Activity Recall, a self-report measure of physical activity and sleep.
Participant steps per day
Steps per day will be verified with data from the Fitbit Alta HR used to calculate steps per day.
Number of participants with food insecurity
The USDA 6-item brief food security measure is a validated tool for assessing household food security. Food security status for each participant at 5 time points over 24 months will be recorded.
Self-reported Nutrition Security, Healthfulness Control, and Utilization Barriers Survey Tool
Each participant self-report answers 4 self-report nutrition security questions, 2 questions about control over the food consumed, and 2 questions about barriers over the last 12 months. Answers choices are a likert scale from Never=0 to Always=4 with higher scores indicating lower levels of nutritional security.
Sample item: "In the last 12 months, (I/we) had to eat some foods that were not good for (my/our) health and well-being because (I/we) could not get other types of food."
Stunkard Figure Rating Scale
Motivation for weightloss will be measured using the Stunkard Figure Rating Scale. This validated tool uses a diagram showing figures of various shapes and sizes and asks the participant to indicate their current body type and the type they would most like to be. Participants are asked to: (1) choose your ideal figure; (2) choose the figure that reflects how you think you look; (3) choose the figure that reflects how you feel most of the time; (4) choose the figure that you think is most preferred by men; (5) choose the figure that you think is most preferred by women; and (6) pick the opposite sex figure that you find most attractive. Scoring uses discrepancy measures: (1) feel minus ideal; (2) think minus ideal; and (3) feel minus think
Thompson, J.K., & Altabe, M.N. (1991). Psychometric qualities of the figure rating scale. International Journal of Eating Disorders, 10(5), 615-619.
Level of anxiety among participants
The validated Generalized Anxiety Scale (GAD-7) will be administered to measure the severity of anxiety that may be present among participants. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 indicate mild, moderate and severe anxiety, respectively.
Bidimensional Acculturation Scale for Hispanics
This validated self-report 24-item tool will be used to understand how participants communicate in both English and Spanish. Each item is a likert-type with answer choices asking participants to rate the frequency they use a communication practice. Answers range from "Almost always (4)" to "Almost never (1)" or "Very well (4)" to "Very Poorly (1)."
COVID-19 Impact on Health and Wellbeing Survey for Health Literacy
Four items were selected from the COVID-19 Impact on Health and Wellbeing Survey to capture how participants receive and process health information such as level of comfort with health forms, medical information, and visiting the doctor.
Full Information
NCT ID
NCT05211180
First Posted
January 13, 2022
Last Updated
September 27, 2022
Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute, San Mateo Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05211180
Brief Title
Vida Sana y Completa Obesity and Food Insecurity Study
Official Title
Vida Sana y Completa Trial: Treating Obesity and Food Insecurity Among Latina Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute, San Mateo Medical Center
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 goal of the Vida Sana y Completa study is to provide evidence on the most effective approach for addressing the critical combination of obesity and food insecurity among Latinas in primary care while also collecting preliminary information on the potential for implementation and dissemination.
Detailed Description
The goal of this study is to compare two approaches to addressing obesity and food insecurity among Latina women in primary care to provide evidence for community health centers who serve this high-priority group. The project team will recruit 412 low-income Latina women with obesity (body mass index 30) and food insecurity from two community health centers with whom the team has longstanding partnerships. Patients will be randomized to Vida Sana y Completa (an obesity intervention with integrated treatment for food insecurity) or Vida Sana alone. Vida Sana is a state-of-the-art cultural adaptation of Group Lifestyle Balance, a 12-month program that targets at least 5 percent weight loss and at least 150 minutes per week of moderate-to-vigorous physical activity. For food insecurity, the team will provide boxes of healthy foods (e.g., fresh produce, lean protein, low-fat dairy, and whole grains) that give women the foods they need to adopt a healthy diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, food insecurity, Latina, fitbit, Metabolic Diseases, Chronic Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study uses a type 1 hybrid design with participants randomized in a 1:1 ratio to either Vida Sana y Completa (an obesity intervention with integrated treatment for food insecurity) or Vida Sana alone (the comparator arm). Vida Sana is a cultural-adaption of Group Lifestyle Balance, a 12-month intervention that targets at least 5% weight loss and at least 150 minutes per week of moderate-to-vigorous physical activity.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will know which group they have been randomized to. The investigator and statistician will not know which group a participant belongs to. Group identifiers will be removed prior to analysis.
Allocation
Randomized
Enrollment
412 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vida Sana
Arm Type
Active Comparator
Arm Description
Vida Sana is a cultural-adaption of Group Lifestyle Balance, a 12-month intervention that targets at least 5% weight loss and at least150 minutes per week of moderate-to-vigorous physical activity. Health coaches will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.
Arm Title
Vida Sana y Completa
Arm Type
Experimental
Arm Description
Vida Sana y Completa is an obesity intervention with integrated treatment for food insecurity. This arm includes all the activities described for the active comparator arm (Vida Sana) as well as a weekly food box delivery for the first 12 weeks of the intervention. The food box will contain approximately 40 pounds of food including proteins and dairy, whole grains, and produce. Just like the Vida Sana active comparator arm, the Vida Sana y Completa group will include health coaches who will facilitate 12 weekly 1-hour group education sessions, followed by nine 30-45 minute individual monthly phone sessions. Health coaches will also conduct two home visits (at baseline and 12-weeks post-enrollment). The health coach will review participant's fitbit health tracking data with them and give personalized feedback.
Intervention Type
Behavioral
Intervention Name(s)
Vida Sana
Intervention Description
Weekly group or individual education sessions with a health coach and fitness tracking with a fitbit.
Intervention Type
Behavioral
Intervention Name(s)
Vida Sana y Completa
Intervention Description
Weekly group or individual education sessions with a health coach, fitness tracking with a fitbit, and weekly food box delivery.
Primary Outcome Measure Information:
Title
Weight change (12 months)
Description
Trained research assistants blinded to treatment assignment will weigh participants in duplicate using a standard calibrated scale at baseline, 12, and 24 months
Time Frame
Baseline, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Self-reported weight
Description
Participants will self-report measures of weight at 6 and 18 months to the health coach via telephone.
Time Frame
6 months, 18 months
Title
Visit or EHR Height, Weight, and Waist Circumference
Description
In person visits at baseline, 12-months and 24-months post enrollment will be used to collect participant weight, height and waist circumference. At baseline, these will be measured twice or in triplicate if there is a discrepancy. Height will be measured in centimeters, weight will be measured in kilograms, and waist circumference will be recorded in centimeters. If participants cannot be weighed in person for the primary outcome, weight measurement from the EHR if available within 3 months of the data collection date will be used.
Waist circumference will be measured according to standard protocols described by the National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual. http://www.cdc.gov/nchs/data/nhanes/nhanes_11_12/Anthropometry_Procedures_Manual.pdf. Published 2011.
Time Frame
baseline, 12 months, 24 months
Title
Health-related quality of life
Description
The validated SF-8™ will be used. It is a generic multipurpose short-form health-related quality of life instrument and was developed by the RAND Corporation and the Medical Outcomes Study (MOS) in the 1980s.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Obesity-specific quality of life
Description
Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at baseline, 6 months, 12 months and at 24 months.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Change in Psychosocial Well-being: Depressive Symptoms
Description
The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items plus a 10th question. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-points for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at baseline, 6 months, 12 months and at 24 months.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Cardiometabolic risk factors
Description
Waist circumference will be measured at baseline, 12 months and at 24 months according to standard protocols described by the National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual. http://www.cdc.gov/nchs/data/nhanes/nhanes_11_12/Anthropometry_Procedures_Manual.pdf. Published 2011. Accessed October 29, 2014.
At baseline, 12 months and at 24 months blood pressure will be measured twice by a trained health coach, a third if there is a discrepancy. Blood pressure, fasting glucose, HbA1c, and lipids will be pulled from the medical record for each time point.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Participant Medication Usage
Description
Participants will be asked to self-report medications/prescriptions. A list of prescribed medications will also be pulled from the electronic health record.
Time Frame
baseline, 12 months, 24 months
Title
Dietary Intake Patterns
Description
Dietary intake will be measured using the gold-standard approach of 3 multiple pass 24-hour recalls (2 during the weekday and 1 on the weekend at each time point). The Nutrition Data System for Research (NDSR), a validated approach, will be used. Changes in dietary intake over 24-months will be assessed.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Food Neophobia Scale
Description
The Food Neophobia Scale (FNS) is a 10-item questionnaire that is comprised of likert type items ranging from "strongly disagree (1)" to "strongly agree (7)." Participants indicate their level of agreement for statements such as "I will eat almost anything" with higher scores indicating greater agreement per item.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Food Attitudes & Behaviors (FAB) Scale for self-efficacy
Description
A subset of 7 items regarding Self-Efficacy to Eat Fruits and Vegetables will be used from the validated Food Attitudes & Behaviors (FAB) scale. These items are answered on a likert scale from "not at all confident" to "very confident" with an option for "does not apply." Scoring details are available on the NIH website (https://cancercontrol.cancer.gov/brp/hbrb/food-attitudes-and-behaviors).
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Second Harvest of Silicon Valley Food Bank Self-Efficacy Measure
Description
Two self-reported items from the Second Harvest of Silicon Valley food bank self-efficacy questionnaire will be asked. They are "In the past few months, have you tried a new recipe using food you received at a free food distribution?" and "And have you tried a new fruit or vegetable that you received at a free food distribution?" Answer choices are yes, no, or I did not receive food.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Participant self-reported 7-day Physical Activity Recall
Description
The research team will administer the 7-day Physical Activity Recall, a self-report measure of physical activity and sleep.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Participant steps per day
Description
Steps per day will be verified with data from the Fitbit Alta HR used to calculate steps per day.
Time Frame
baseline, 6 months, 12 months, 18 months, 24 months
Title
Number of participants with food insecurity
Description
The USDA 6-item brief food security measure is a validated tool for assessing household food security. Food security status for each participant at 5 time points over 24 months will be recorded.
Time Frame
baseline, 6 months, 12 months, 18 months, 24 months
Title
Self-reported Nutrition Security, Healthfulness Control, and Utilization Barriers Survey Tool
Description
Each participant self-report answers 4 self-report nutrition security questions, 2 questions about control over the food consumed, and 2 questions about barriers over the last 12 months. Answers choices are a likert scale from Never=0 to Always=4 with higher scores indicating lower levels of nutritional security.
Sample item: "In the last 12 months, (I/we) had to eat some foods that were not good for (my/our) health and well-being because (I/we) could not get other types of food."
Time Frame
baseline, 6 months, 12 months, 18 months, 24 months
Title
Stunkard Figure Rating Scale
Description
Motivation for weightloss will be measured using the Stunkard Figure Rating Scale. This validated tool uses a diagram showing figures of various shapes and sizes and asks the participant to indicate their current body type and the type they would most like to be. Participants are asked to: (1) choose your ideal figure; (2) choose the figure that reflects how you think you look; (3) choose the figure that reflects how you feel most of the time; (4) choose the figure that you think is most preferred by men; (5) choose the figure that you think is most preferred by women; and (6) pick the opposite sex figure that you find most attractive. Scoring uses discrepancy measures: (1) feel minus ideal; (2) think minus ideal; and (3) feel minus think
Thompson, J.K., & Altabe, M.N. (1991). Psychometric qualities of the figure rating scale. International Journal of Eating Disorders, 10(5), 615-619.
Time Frame
baseline
Title
Level of anxiety among participants
Description
The validated Generalized Anxiety Scale (GAD-7) will be administered to measure the severity of anxiety that may be present among participants. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 indicate mild, moderate and severe anxiety, respectively.
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Bidimensional Acculturation Scale for Hispanics
Description
This validated self-report 24-item tool will be used to understand how participants communicate in both English and Spanish. Each item is a likert-type with answer choices asking participants to rate the frequency they use a communication practice. Answers range from "Almost always (4)" to "Almost never (1)" or "Very well (4)" to "Very Poorly (1)."
Time Frame
baseline
Title
COVID-19 Impact on Health and Wellbeing Survey for Health Literacy
Description
Four items were selected from the COVID-19 Impact on Health and Wellbeing Survey to capture how participants receive and process health information such as level of comfort with health forms, medical information, and visiting the doctor.
Time Frame
baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: Lower age limit - 18 years, Upper age limit - NONE
Race/ethnicity: self-reported Latinx ethnicity
Sex: Female
Body mass index: ≥ 30 kg/m2
One or more metabolic risk factors as follows:
Fasting plasma glucose of 100 to 125 mg/dL or HbA1c of 5.7 to 6.4 if detected by a recent (within the past year), documented, blood-based diagnostic test in the Electronic Health Record (EHR) in the last year
Waist circumference >40 inches in men and >35 inches in women (≥35 inches in men and ≥31 inches in women, if of Asian descent) as measured by the study coordinator
Triglycerides >150 mg/dL as documented in the EHR in the last year
High-density lipoprotein cholesterol (HDL-C) <40 mg/dL in men and <50 mg/dL in women as documented in the EHR in the last year
Systolic blood pressure >120 mmHg or diastolic blood pressure >80 mmHg as measured by study coordinator
Food insecurity: Defined as answering yes to one or both questions of the Hunger Vital Sign
PCP approval of patient contact for study screening
Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of 2 study arms, participate for 24 months, and authorize extraction of relevant information from the EHR.
Exclusion Criteria:
Previous diagnosis of diabetes (other than during pregnancy) or diabetes documented in the EHR
Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years
Serious medical condition anticipated to prevent person from walking
1 mile (e.g., severe pulmonary disease or aortic stenosis)
Severe medical comorbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
Diagnosis of a terminal illness and/or in hospice care;
Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
Have had or plan to undergo bariatric surgery during the study period
Other exclusions:
Inability to speak, read or understand Spanish
Having no reliable telephone service
Having no regular Internet access via a computer and/or mobile device (e.g., smartphone)
Plan to move out of the area during the study period
Planned pregnancy
Family/household member of another study participant or of a study staff member
Investigator discretion for clinical safety or protocol adherence reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Ordonez Arango
Phone
(650) 723 2080
Email
mordonez@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Goldman Rosas, PhD, MPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei-ting Chen, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
San Mateo Medical Center Fair Oaks Health Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanette Aviles
Email
javiles@smcgov.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be made available to other researchers
Citations:
PubMed Identifier
26029126
Citation
Ceccarini M, Borrello M, Pietrabissa G, Manzoni GM, Castelnuovo G. Assessing motivation and readiness to change for weight management and control: an in-depth evaluation of three sets of instruments. Front Psychol. 2015 May 11;6:511. doi: 10.3389/fpsyg.2015.00511. eCollection 2015.
Results Reference
background
PubMed Identifier
22248993
Citation
Andres A, Saldana C, Gomez-Benito J. The transtheoretical model in weight management: validation of the processes of change questionnaire. Obes Facts. 2011;4(6):433-42. doi: 10.1159/000335135. Epub 2011 Nov 25.
Results Reference
background
PubMed Identifier
29246567
Citation
Gibbs HD, Ellerbeck EF, Gajewski B, Zhang C, Sullivan DK. The Nutrition Literacy Assessment Instrument is a Valid and Reliable Measure of Nutrition Literacy in Adults with Chronic Disease. J Nutr Educ Behav. 2018 Mar;50(3):247-257.e1. doi: 10.1016/j.jneb.2017.10.008. Epub 2017 Dec 12.
Results Reference
background
PubMed Identifier
1489209
Citation
Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w.
Results Reference
background
Citation
Thompson, J.K., & Altabe, M.N. (1991). Psychometric qualities of the figure rating scale. International Journal of Eating Disorders, 10(5), 615-619.
Results Reference
background
Links:
URL
https://cancercontrol.cancer.gov/brp/hbrb/food-attitudes-and-behaviors
Description
Food Attitudes and Behaviors (FAB) from NIH
URL
http://www.cdc.gov/nchs/data/nhanes/nhanes_11_12/Anthropometry_Procedures_Manual.pdf.
Description
National Health and Nutrition Examination Surveys (NHANES) Anthropometry Procedures Manual
Learn more about this trial
Vida Sana y Completa Obesity and Food Insecurity Study
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