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

Pre-diabetes Clinical Trial

— HEED  

Official title:

Collaborations for Health Improvement in East Harlem—Project HEED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004848
• Other study ID #: GCO 05-0463
• Status: Completed
• Phase: N/A
• First received: October 29, 2009
• Last updated: October 22, 2014
• Start date: March 2009
• Est. completion date: September 2012

Study information

• Verified date: October 2014
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: September 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Albert Einstein College of Medicine of Yeshiva University, North General Hospital, New York, Union Settlement Association, New York

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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. — View 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. — View 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. Erratum in: Diabetes Care. 2011 Oct;34(10):2338. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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:S232-9. doi: 10.2105/AJPH.2009.170910. Epub 2010 Feb 10 — View Citation

Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight From Baseline to 6 Months		Change from Baseline to 6 Months	No
Secondary	Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months	Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline	Change from Baseline to 6 Months	No
Secondary	Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months	Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline	Change in 6 Months from Baseline	No
Secondary	Change in Systolic Blood Pressure From Baseline to 6 Months		Change from Baseline to 6 Months	No
Secondary	Change in Diastolic Blood Pressure From Baseline to 6 Months		Change from Baseline to 6 Months	No
Secondary	Waist Circumference		Change from Baseline to 6 Months	No
Secondary	LDL Cholesterol		Change from Baseline to 6 Months	No
Secondary	HDL Cholesterol		Change from Baseline to 6 Months	No
Secondary	Total Cholesterol		Change from Baseline to 6 Months	No
Secondary	Triglycerides		Change from Baseline to 6 Months	No
Secondary	HbA1c		Change from Baseline to 6 Months	No
Secondary	Energy Expenditure	percent energy expenditure	Change from Baseline to 6 Months	No
Secondary	Fiber Intake		Change from Baseline to 6 Months	No
Secondary	Physical Activity (Self-report)		6 months	No
Secondary	Knowledge & Attitudes About Diabetes Risk		6 months	No