Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of a peer-led community-based lifestyle intervention, versus usual care, in achieving weight loss and prevention of diabetes among overweight adults with pre-diabetes in East Harlem.

Detailed Description
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Weight loss can prevent diabetes and eliminate racial and ethnic disparities in incident diabetes among overweight adults with pre-diabetes. However, proven effective interventions have not been sustained or disseminated in community settings. A community-academic partnership aims to employ community-based participatory research to conduct a randomized controlled trial to test the effectiveness of a culturally tailored, peer-led diabetes prevention intervention that promotes weight loss. People who develop diabetes go through a period when they have pre-diabetes. In clinical settings, overweight adults with pre-diabetes who reduce their weight by 5-10% can reduce their risk of developing diabetes by 55-60%. To date, there are no studies testing the effectiveness of peer-led, community-based programs in achieving diabetes prevention through weight loss. We will identify and enroll 400 overweight (BMI > 25) adults with pre-diabetes in East Harlem and randomized half into a community-based, peer-led lifestyle education program that teaches simple ways to lose weight.

Official Title
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Collaborations for Health Improvement in East Harlem-Project HEED

Conditions
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Pre-diabetes

Intervention / Treatment
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* Behavioral: Peer-Led Lifestyle Education on Weight Loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Residents of East Harlem or members of an East Harlem Institution in zip codes 10029, 10035, OR in the section of 10037 east of Fifth Avenue BMI ≥ 25 AND pre-diabetes glucose values, defined as fasting fingerstick glucose of 100-125mg/dl and/or glucose 2 hours after an oral glucose load of 140-199 mg/dl Able to communicate verbally to participate in a group education class English or Spanish speaking Exclusion Criteria: < 18 years Previous diagnosis of diabetes BMI <25 Fingerstick glucoses outside pre-diabetes level ranges Currently pregnant On medications that may raise or lower blood glucose Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak) Self-reported terminal illness with life expectancy of less than 1 year Plans to relocate from New York City within one year of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer-Led Lifestyle Education on Weight Loss<br>Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes. The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes. | Behavioral: Peer-Led Lifestyle Education on Weight Loss<br>* Project HEED (Help Educate to Eliminate Diabetes) is a bilingual lifestyle education program written at a 4th grade reading level, and contains simple, actionable, messages, is easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes. It consists of 8 sessions (1½ hours each) held over 10-weeks. Topics include diabetes prevention, finding and affording healthy foods, label reading, fun physical activity, planning a healthy plate, making traditional foods healthy, and portion control.<br>* Other names: Project HEED;|
| Placebo Comparator: Delayed Intervention<br>The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial. | Behavioral: Peer-Led Lifestyle Education on Weight Loss<br>* Project HEED (Help Educate to Eliminate Diabetes) is a bilingual lifestyle education program written at a 4th grade reading level, and contains simple, actionable, messages, is easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes. It consists of 8 sessions (1½ hours each) held over 10-weeks. Topics include diabetes prevention, finding and affording healthy foods, label reading, fun physical activity, planning a healthy plate, making traditional foods healthy, and portion control.<br>* Other names: Project HEED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight From Baseline to 6 Months |  | Change from Baseline to 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months | Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline | Change from Baseline to 6 Months | 
| Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months | Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline | Change in 6 Months from Baseline | 
| Change in Systolic Blood Pressure From Baseline to 6 Months |  | Change from Baseline to 6 Months | 
| Change in Diastolic Blood Pressure From Baseline to 6 Months |  | Change from Baseline to 6 Months | 
| Waist Circumference |  | Change from Baseline to 6 Months | 
| LDL Cholesterol |  | Change from Baseline to 6 Months | 
| HDL Cholesterol |  | Change from Baseline to 6 Months | 
| Total Cholesterol |  | Change from Baseline to 6 Months | 
| Triglycerides |  | Change from Baseline to 6 Months | 
| HbA1c |  | Change from Baseline to 6 Months | 
| Energy Expenditure | percent energy expenditure | Change from Baseline to 6 Months | 
| Fiber Intake |  | Change from Baseline to 6 Months | 
| Physical Activity (Self-report) |  | 6 months | 
| Knowledge & Attitudes About Diabetes Risk |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-diabetes, pre-diabetic state, community-based participatory research, overweight, weight loss intervention, peer-led lifestyle education