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Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes (HEED)
This study is ongoing, but not recruiting participants.

First Received on October 29, 2009.   Last Updated on January 31, 2012   History of Changes
Sponsor: Mount Sinai School of Medicine
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
  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: Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Pre-diabetes Weight Control
U.S. FDA Resources

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
Estimated 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
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: Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
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.
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: Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.
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.

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

Locations
United States, New York
Mount Sinai School of Medicine
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:
Parikh P, Simon EP, Fei K, Looker H, Goytia C, Horowitz CR. Results of a pilot diabetes prevention intervention in East Harlem, New York City: Project HEED. Am J Public Health. 2010 Apr 1;100 Suppl 1:S232-9. Epub 2010 Feb 10.
Goldfinger JZ, Arniella G, Wylie-Rosett J, Horowitz CR. Project HEAL: peer education leads to weight loss in Harlem. J Health Care Poor Underserved. 2008 Feb;19(1):180-92.
Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, Williams DE, Gregg EW, Bainbridge KE, Saydah SH, Geiss LS. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009 Feb;32(2):287-94. Epub 2008 Nov 18.
Cowie CC, Rust KF, Byrd-Holt DD, Eberhardt MS, Flegal KM, Engelgau MM, Saydah SH, Williams DE, Geiss LS, Gregg EW. Prevalence of diabetes and impaired fasting glucose in adults in the U.S. population: National Health And Nutrition Examination Survey 1999-2002. Diabetes Care. 2006 Jun;29(6):1263-8.
Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.
Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, Hoskin M, Kriska AM, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner J, Venditti B, Wylie-Rosett J. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006 Sep;29(9):2102-7.
Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44.
Biuso TJ, Butterworth S, Linden A. A conceptual framework for targeting prediabetes with lifestyle, clinical, and behavioral management interventions. Dis Manag. 2007 Feb;10(1):6-15. Review.
Horowitz CR, Brenner BL, Lachapelle S, Amara DA, Arniella G. Effective recruitment of minority populations through community-led strategies. Am J Prev Med. 2009 Dec;37(6 Suppl 1):S195-200.

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: January 31, 2012
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 February 09, 2012



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