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

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ClinicalTrials.gov Identifier: NCT01004848
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Collaborators:
North General Hospital, New York
Albert Einstein College of Medicine
Union Settlement Association, New York
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE October 29, 2009
First Posted Date  ICMJE October 30, 2009
Results First Submitted Date  ICMJE September 4, 2013
Results First Posted Date  ICMJE October 23, 2014
Last Update Posted Date October 23, 2014
Study Start Date  ICMJE March 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
Change in Weight From Baseline to 6 Months [ Time Frame: Change from Baseline to 6 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Weight loss [ Time Frame: 6, 12, and 24 months post-enrollment into trial ]
Change History Complete list of historical versions of study NCT01004848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
  • Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months [ Time Frame: Change from Baseline to 6 Months ]
    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 ]
    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 ]
  • Change in Diastolic Blood Pressure From Baseline to 6 Months [ Time Frame: Change from Baseline to 6 Months ]
  • Waist Circumference [ Time Frame: Change from Baseline to 6 Months ]
  • LDL Cholesterol [ Time Frame: Change from Baseline to 6 Months ]
  • HDL Cholesterol [ Time Frame: Change from Baseline to 6 Months ]
  • Total Cholesterol [ Time Frame: Change from Baseline to 6 Months ]
  • Triglycerides [ Time Frame: Change from Baseline to 6 Months ]
  • HbA1c [ Time Frame: Change from Baseline to 6 Months ]
  • Energy Expenditure [ Time Frame: Change from Baseline to 6 Months ]
    percent energy expenditure
  • Fiber Intake [ Time Frame: Change from Baseline to 6 Months ]
  • Physical Activity (Self-report) [ Time Frame: 6 months ]
  • Knowledge & Attitudes About Diabetes Risk [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
  • Outcome Measure: Fasting fingerstick glucose [ Time Frame: 6, 12, and 24 months ]
  • Post-prandial fingerstick glucose [ Time Frame: 6, 12, and 24 months ]
  • Systolic and diastolic blood pressure [ Time Frame: 6, 12, and 24 months ]
  • Waist Circumference [ Time Frame: 6, 12, and 24 months ]
  • LDL Cholesterol [ Time Frame: 6, 12, and 24 months ]
  • HDL Cholesterol [ Time Frame: 6, 12, and 24 months ]
  • Total Cholesterol [ Time Frame: 6, 12, and 24 months ]
  • Triglycerides [ Time Frame: 6, 12, and 24 months ]
  • HbA1c [ Time Frame: 6, 12, and 24 months ]
  • Dietary behaviors (self-report [ Time Frame: 6, 12, and 24 months ]
  • Physical Activity (Self-report) [ Time Frame: 6, 12, and 24 months ]
  • Knowledge & Attitudes About Diabetes Risk [ Time Frame: 6, 12, and 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes
Official Title  ICMJE Collaborations for Health Improvement in East Harlem—Project HEED
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pre-diabetes
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2014)
402
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2009)
400
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004848
Other Study ID Numbers  ICMJE GCO 05-0463
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE
  • North General Hospital, New York
  • Albert Einstein College of Medicine
  • Union Settlement Association, New York
Investigators  ICMJE
Principal Investigator: Carol R Horowitz, MD, MPH Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date October 2014

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