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

Primary Purpose

Pre-diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Peer-Led Lifestyle Education on Weight Loss

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring Pre-diabetes, pre-diabetic state, community-based participatory research, overweight, weight loss intervention, peer-led lifestyle education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Peer-Led Lifestyle Education on Weight Loss

Delayed Intervention

Arm Description

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.

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.

Outcomes

Primary Outcome Measures

Change in Weight From Baseline to 6 Months

Secondary Outcome Measures

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 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 Systolic Blood Pressure From Baseline to 6 Months

Change in Diastolic Blood Pressure From Baseline to 6 Months

Waist Circumference

LDL Cholesterol

HDL Cholesterol

Total Cholesterol

Triglycerides

HbA1c

Energy Expenditure

percent energy expenditure

Fiber Intake

Physical Activity (Self-report)

Knowledge & Attitudes About Diabetes Risk

Full Information

NCT ID

NCT01004848

First Posted

October 29, 2009

Last Updated

October 22, 2014

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

North General Hospital, New York, Albert Einstein College of Medicine, Union Settlement Association, New York

1. Study Identification

Unique Protocol Identification Number

NCT01004848

Brief Title

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

Acronym

HEED

Official Title

Collaborations for Health Improvement in East Harlem-Project HEED

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

North General Hospital, New York, Albert Einstein College of Medicine, Union Settlement Association, New York

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes

Keywords

Pre-diabetes, pre-diabetic state, community-based participatory research, overweight, weight loss intervention, peer-led lifestyle education

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

402 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peer-Led Lifestyle Education on Weight Loss

Arm Type

Experimental

Arm Description

Arm Title

Delayed Intervention

Arm Type

Placebo Comparator

Arm Description

The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.

Intervention Type

Behavioral

Intervention Name(s)

Peer-Led Lifestyle Education on Weight Loss

Other Intervention Name(s)

Project HEED

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Weight From Baseline to 6 Months

Time Frame

Change from Baseline to 6 Months

Secondary Outcome Measure Information:

Title

Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months

Description

Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline

Time Frame

Change from Baseline to 6 Months

Title

Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months

Description

Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline

Time Frame

Change in 6 Months from Baseline

Title

Change in Systolic Blood Pressure From Baseline to 6 Months

Time Frame

Change from Baseline to 6 Months

Title

Change in Diastolic Blood Pressure From Baseline to 6 Months

Time Frame

Change from Baseline to 6 Months

Title

Waist Circumference

Time Frame

Change from Baseline to 6 Months

Title

LDL Cholesterol

Time Frame

Change from Baseline to 6 Months

Title

HDL Cholesterol

Time Frame

Change from Baseline to 6 Months

Title

Total Cholesterol

Time Frame

Change from Baseline to 6 Months

Title

Triglycerides

Time Frame

Change from Baseline to 6 Months

Title

HbA1c

Time Frame

Change from Baseline to 6 Months

Title

Energy Expenditure

Description

percent energy expenditure

Time Frame

Change from Baseline to 6 Months

Title

Fiber Intake

Time Frame

Change from Baseline to 6 Months

Title

Physical Activity (Self-report)

Time Frame

6 months

Title

Knowledge & Attitudes About Diabetes Risk

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol R Horowitz, MD, MPH

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18263994

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.

Results Reference

background

PubMed Identifier

19017771

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.

Results Reference

background

PubMed Identifier

16732006

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.

Results Reference

background

PubMed Identifier

11333990

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.

Results Reference

background

PubMed Identifier

11832527

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.

Results Reference

background

PubMed Identifier

16936160

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.

Results Reference

background

PubMed Identifier

9096977

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.

Results Reference

background

PubMed Identifier

17309360

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.

Results Reference

background

PubMed Identifier

19896019

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.

Results Reference

background

PubMed Identifier

22848797

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.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

22811889

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.

Results Reference

background

PubMed Identifier

20147680

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.

Results Reference

result

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

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