Clinical trial NCT01004848: Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes
Official title: Collaborations for Health Improvement in East Harlem-Project HEED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Keywords: Pre-diabetes
pre-diabetic state
community-based participatory research
overweight
weight loss intervention, peer-led lifestyle education
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: North General Hospital, New York
name: Albert Einstein College of Medicine
name: Union Settlement Association, New York
First posted: 2009-10-30
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in Weight From Baseline to 6 Months
timeFrame: Change from Baseline to 6 Months
Secondary outcomes:
measure: Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months
timeFrame: Change from Baseline to 6 Months
measure: Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months
timeFrame: Change in 6 Months from Baseline
measure: Change in Systolic Blood Pressure From Baseline to 6 Months
timeFrame: Change from Baseline to 6 Months
measure: Change in Diastolic Blood Pressure From Baseline to 6 Months
timeFrame: Change from Baseline to 6 Months
measure: Waist Circumference
timeFrame: Change from Baseline to 6 Months
measure: LDL Cholesterol
timeFrame: Change from Baseline to 6 Months
measure: HDL Cholesterol
timeFrame: Change from Baseline to 6 Months
measure: Total Cholesterol
timeFrame: Change from Baseline to 6 Months
measure: Triglycerides
timeFrame: Change from Baseline to 6 Months
measure: HbA1c
timeFrame: Change from Baseline to 6 Months
measure: Energy Expenditure
timeFrame: Change from Baseline to 6 Months
measure: Fiber Intake
timeFrame: Change from Baseline to 6 Months
measure: Physical Activity (Self-report)
timeFrame: 6 months
measure: Knowledge & Attitudes About Diabetes Risk
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Carol R Horowitz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1353/hpu.2008.0016.
citation: 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. doi: 10.2337/dc08-1296. Epub 2008 Nov 18.
citation: 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. doi: 10.2337/dc06-0062.
citation: 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. doi: 10.1056/NEJM200105033441801.
citation: 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. doi: 10.1056/NEJMoa012512.
citation: 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. doi: 10.2337/dc06-0560.
citation: 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. doi: 10.2337/diacare.20.4.537.
citation: 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. doi: 10.1089/dis.2006.628.
citation: 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. doi: 10.1016/j.amepre.2009.08.006.
citation: Fox AM, Mann DM, Ramos MA, Kleinman LC, Horowitz CR. Barriers to physical activity in East harlem, new york. J Obes. 2012;2012:719140. doi: 10.1155/2012/719140. Epub 2012 Jul 12.
citation: Fei K, Fox A, Horowitz CR, Lee E. Family History and Perceptions of Control over Risk for Diabetes, SGIM Supplement 2012. PMC Journal - In Process.
citation: Breland JY, Fox AM, Horowitz CR, Leventhal H. Applying a common-sense approach to fighting obesity. J Obes. 2012;2012:710427. doi: 10.1155/2012/710427. Epub 2012 Jun 28.
citation: 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(Suppl 1):S232-9. doi: 10.2105/AJPH.2009.170910. Epub 2010 Feb 10.