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

Mount Sinai Health System

Status: Completed

Conditions: Pre-diabetes

Treatments: Behavioral: Peer-Led Lifestyle Education on Weight Loss

Study type: Interventional

Funder types: Other

Identifiers

NCT01004848

GCO 05-0463

Details and patient eligibility

About

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.

Full 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.

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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402 participants in 2 patient groups, including a placebo group

Peer-Led Lifestyle Education on Weight Loss

Experimental group

Description:

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.

Treatment:

Behavioral: Peer-Led Lifestyle Education on Weight Loss

Delayed Intervention

Placebo Comparator group

Description:

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.

Treatment:

Behavioral: Peer-Led Lifestyle Education on Weight Loss