Clinical Trials Directory

Trials / Completed

CompletedNCT01004848

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

Collaborations for Health Improvement in East Harlem-Project HEED

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
402 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPeer-Led Lifestyle Education on Weight LossProject 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.

Timeline

Start date
2009-03-01
Primary completion
2011-07-01
Completion
2012-09-01
First posted
2009-10-30
Last updated
2014-10-23
Results posted
2014-10-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01004848. Inclusion in this directory is not an endorsement.