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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Peer-Led Lifestyle Education on Weight Loss	Peer-Led Lifestyle Education on Weight Loss	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.
Delayed Intervention	Peer-Led Lifestyle Education on Weight Loss	The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.

Primary Outcome Measures

Name	Time	Method
Change in Weight From Baseline to 6 Months	Change from Baseline to 6 Months

Secondary Outcome Measures

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