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

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT01004848
• Collaborator: North General Hospital, New York (Other), Albert Einstein College of Medicine (Other), Union Settlement Association, New York (Other)
• Enrollment: 402
• Location: 1
• Arms: 2
• Duration (Months): 42.1
• Patients Per Site Per Month: 9.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-diabetes	Behavioral: Peer-Led Lifestyle Education on Weight Loss	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 402 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Collaborations for Health Improvement in East Harlem-Project HEED
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	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 Names: Project HEED
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: 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 Names: Project HEED

Outcome Measures

Primary Outcome Measures

1. Change in Weight From Baseline to 6 Months [Change from Baseline to 6 Months]

Secondary Outcome Measures

1. Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months [Change from Baseline to 6 Months]

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

2. Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months [Change in 6 Months from Baseline]

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

3. Change in Systolic Blood Pressure From Baseline to 6 Months [Change from Baseline to 6 Months]

4. Change in Diastolic Blood Pressure From Baseline to 6 Months [Change from Baseline to 6 Months]

5. Waist Circumference [Change from Baseline to 6 Months]

6. LDL Cholesterol [Change from Baseline to 6 Months]

7. HDL Cholesterol [Change from Baseline to 6 Months]

8. Total Cholesterol [Change from Baseline to 6 Months]

9. Triglycerides [Change from Baseline to 6 Months]

10. HbA1c [Change from Baseline to 6 Months]

11. Energy Expenditure [Change from Baseline to 6 Months]

    percent energy expenditure

12. Fiber Intake [Change from Baseline to 6 Months]

13. Physical Activity (Self-report) [6 months]

14. Knowledge & Attitudes About Diabetes Risk [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• North General Hospital, New York
• Albert Einstein College of Medicine
• Union Settlement Association, New York

Investigators

• Principal Investigator: Carol R Horowitz, MD, MPH, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01004848
• Other Study ID Numbers: GCO 05-0463
• First Posted: Oct 30, 2009
• Last Update Posted: Oct 23, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Icahn School of Medicine at Mount Sinai: Pre-diabetes; pre-diabetic state; community-based participatory research; overweight; weight loss intervention, peer-led lifestyle education
• Additional relevant MeSH terms: Prediabetic State; Glucose Intolerance

Study Results

Participant Flow

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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 participated 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 was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Period Title: Overall Study
STARTED	210	192
COMPLETED	155	147
NOT COMPLETED	55	45

Baseline Characteristics

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention	Total
Arm/Group 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 participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aimed to help participants lose weight, thereby preventing their progression to diabetes.	The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.	Total of all reporting groups
Overall Participants	210	192	402
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	186 88.6%	170 88.5%	356 88.6%
>=65 years	24 11.4%	22 11.5%	46 11.4%
Sex: Female, Male (Count of Participants)
Female	178 84.8%	165 85.9%	343 85.3%
Male	32 15.2%	27 14.1%	59 14.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	153 72.9%	141 73.4%	294 73.1%
Not Hispanic or Latino	55 26.2%	48 25%	103 25.6%
Unknown or Not Reported	2 1%	3 1.6%	5 1.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 1%	2 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	52 24.8%	41 21.4%	93 23.1%
White	0 0%	3 1.6%	3 0.7%
More than one race	3 1.4%	2 1%	5 1.2%
Unknown or Not Reported	155 73.8%	144 75%	299 74.4%

Outcome Measures

1. Primary Outcome

Title	Change in Weight From Baseline to 6 Months
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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 participated 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 was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Measure Participants	155	147
Mean (Standard Deviation) [pounds]	-2.85 (7.42)	-1.13 (7.11)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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 participated 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 was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Measure Participants	155	147
Mean (Standard Deviation) [mg/dL]	-1.79 (9.41)	-0.47 (9.98)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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 participated 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 was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Measure Participants	155	147
Mean (Standard Deviation) [mg/dL]	1.41 (26.59)	3.85 (33.14)

4. Secondary Outcome

Title	Change in Systolic Blood Pressure From Baseline to 6 Months
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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 participated 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 was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Measure Participants	155	147
Mean (Standard Deviation) [mmHg]	-1.39 (11.84)	-1.45 (12.77)

5. Secondary Outcome

Title	Change in Diastolic Blood Pressure From Baseline to 6 Months
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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 participated 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 was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
Measure Participants	155	147
Mean (Standard Deviation) [mmHg]	-0.47 (8.33)	-1.07 (7.96)

6. Secondary Outcome

Title	Waist Circumference
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [inches]	-0.5 (1.99)	-0.29 (2.06)

7. Secondary Outcome

Title	LDL Cholesterol
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [mg/dl]	-2.93 (18.17)	-1.18 (17.87)

8. Secondary Outcome

Title	HDL Cholesterol
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [mg/dl]	0.68 (8.26)	.029 (7.17)

9. Secondary Outcome

Title	Total Cholesterol
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [mg/dl]	-2.78 (21.37)	-0.66 (20.22)

10. Secondary Outcome

Title	Triglycerides
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [mg/dl]	-0.1 (52.95)	2.92 (57.39)

11. Secondary Outcome

Title	HbA1c
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [percent change]	0.03 (0.0485)	1.20 (0.0553)

12. Secondary Outcome

Title	Energy Expenditure
Description	percent energy expenditure
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [percent expenditure/day]	-58.08 (1.6429)	-12.54 (0.6594)

13. Secondary Outcome

Title	Fiber Intake
Time Frame	Change from Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss	Delayed Intervention
Arm/Group 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.
Measure Participants	155	147
Mean (Standard Deviation) [grams per day]	-0.19 (0.6377)	0.013 (0.6594)

14. Secondary Outcome

Title	Physical Activity (Self-report)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	Knowledge & Attitudes About Diabetes Risk
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	not applicable - adverse events not collected
Arm/Group Title	Peer-Led Lifestyle Education on Weight Loss		Delayed Intervention
Arm/Group 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.
All Cause Mortality
	Peer-Led Lifestyle Education on Weight Loss		Delayed Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Peer-Led Lifestyle Education on Weight Loss		Delayed Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Peer-Led Lifestyle Education on Weight Loss		Delayed Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.