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

This study has been completed.
Sponsor:
Collaborators:
North General Hospital, New York
Albert Einstein College of Medicine of Yeshiva University
Union Settlement Association, New York
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01004848
First received: October 29, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Pre-diabetes
Behavioral: Peer-Led Lifestyle Education on Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Collaborations for Health Improvement in East Harlem—Project HEED

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 6, 12, and 24 months post-enrollment into trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Outcome Measure: Fasting fingerstick glucose [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Post-prandial fingerstick glucose [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Dietary behaviors (self-report [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Physical activity (self-report) [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Knowledge & attitudes about diabetes risk [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: March 2009
Study Completion Date: September 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Behavioral: Peer-Led Lifestyle Education on Weight Loss
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.
Other Name: Project HEED
Placebo Comparator: Delayed Intervention
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
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.
Other Name: Project HEED

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004848

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
North General Hospital, New York
Albert Einstein College of Medicine of Yeshiva University
Union Settlement Association, New York
Investigators
Principal Investigator: Carol R Horowitz, MD, MPH Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01004848     History of Changes
Other Study ID Numbers: GCO# 05-0463
Study First Received: October 29, 2009
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Pre-diabetes
pre-diabetic state
community-based participatory research
overweight
weight loss intervention, peer-led lifestyle education

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on August 19, 2014