Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01004848
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date September 2012

See also
  Status Clinical Trial Phase
Completed NCT04082585 - Total Health Improvement Program Research Project
Enrolling by invitation NCT05367024 - Broccoli Effect on Glycated Haemoglobin (HbA1c) N/A
Withdrawn NCT02400450 - Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes N/A
Completed NCT02933424 - Project Plant Protein: the P3 Study in Humans N/A
Completed NCT02656212 - Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2) Phase 1
Completed NCT02330276 - Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin Phase 1
Completed NCT01488279 - Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy N/A
Completed NCT00831129 - A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs Phase 2/Phase 3
Completed NCT00536250 - Study to Investigate the Pathophysiology of Type 2 Diabetes in Youth N/A
Recruiting NCT05563090 - Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Active, not recruiting NCT04991142 - Models of Nutrition From Continuous Glucose Monitors
Completed NCT02759055 - Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard) N/A
Completed NCT00775684 - Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass N/A
Completed NCT03695913 - Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes N/A
Completed NCT04051008 - CTSI Pilot: Improving Adherence to Diabetic Diet N/A
Recruiting NCT04897945 - A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus N/A
Not yet recruiting NCT04442451 - Mechanisms of Fatigability With Diabetes N/A
Not yet recruiting NCT05925933 - High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes N/A
Active, not recruiting NCT05654051 - The SLIM LIVER Study Phase 2
Completed NCT02919397 - Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes N/A