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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: October 22, 2014
Last verified: October 2014

October 29, 2009
October 22, 2014
March 2009
July 2011   (final data collection date for primary outcome measure)
Change in Weight From Baseline to 6 Months [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
Weight loss [ Time Frame: 6, 12, and 24 months post-enrollment into trial ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01004848 on ClinicalTrials.gov Archive Site
  • Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
    Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline
  • Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months [ Time Frame: Change in 6 Months from Baseline ] [ Designated as safety issue: No ]
    Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline
  • Change in Systolic Blood Pressure From Baseline to 6 Months [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to 6 Months [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • Waist Circumference [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • HDL Cholesterol [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • Total Cholesterol [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • Energy Expenditure [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
    percent energy expenditure
  • Fiber Intake [ Time Frame: Change from Baseline to 6 Months ] [ Designated as safety issue: No ]
  • Physical Activity (Self-report) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Knowledge & Attitudes About Diabetes Risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes
Collaborations for Health Improvement in East Harlem—Project HEED

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pre-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
  • 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.

    Intervention: Behavioral: Peer-Led Lifestyle Education on Weight Loss
  • 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.
    Intervention: Behavioral: Peer-Led Lifestyle Education on Weight Loss

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
September 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01004848
GCO 05-0463
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
  • North General Hospital, New York
  • Albert Einstein College of Medicine of Yeshiva University
  • Union Settlement Association, New York
Principal Investigator: Carol R Horowitz, MD, MPH Mount Sinai School of Medicine
Mount Sinai School of Medicine
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP