Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| North General Hospital, New York | OTHER |
| Albert Einstein College of Medicine | OTHER |
| Union Settlement Association, New York | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Experimental | 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. |
|
| Delayed Intervention | Placebo Comparator | The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer-Led Lifestyle Education on Weight Loss | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Baseline to 6 Months | Change from Baseline to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carol R Horowitz, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18263994 | Background | 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. | |
| 19017771 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | Delayed Intervention | The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight From Baseline to 6 Months | Posted | Mean | Standard Deviation | pounds | Change from Baseline to 6 Months |
|
Not provided
not applicable - adverse events not collected
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol R. Horowitz, MD, MPH | Icahn School of Medicine at Mount Sinai | 212-659-9567 | carol.horowitz@mountsinai.org |
Not provided
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline |
| Change in 6 Months from Baseline |
| Change in Systolic Blood Pressure From Baseline to 6 Months | Change from Baseline to 6 Months |
| Change in Diastolic Blood Pressure From Baseline to 6 Months | Change from Baseline to 6 Months |
| Waist Circumference | Change from Baseline to 6 Months |
| LDL Cholesterol | Change from Baseline to 6 Months |
| HDL Cholesterol | Change from Baseline to 6 Months |
| Total Cholesterol | Change from Baseline to 6 Months |
| Triglycerides | Change from Baseline to 6 Months |
| HbA1c | Change from Baseline to 6 Months |
| Energy Expenditure | percent energy expenditure | Change from Baseline to 6 Months |
| Fiber Intake | Change from Baseline to 6 Months |
| Physical Activity (Self-report) | 6 months |
| Knowledge & Attitudes About Diabetes Risk | 6 months |
| 16732006 | Background | 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. |
| 11333990 | Background | 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. |
| 11832527 | Background | 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. |
| 16936160 | Background | 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. |
| 9096977 | Background | 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. |
| 17309360 | Background | 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. |
| 19896019 | Background | 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. |
| 22848797 | Background | 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. |
| Background | 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. |
| 22811889 | Background | 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. |
| 20147680 | Result | 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. |
| BG001 | Delayed Intervention | The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/dL | Change from Baseline to 6 Months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/dL | Change in 6 Months from Baseline |
|
|
|
| Secondary | Change in Systolic Blood Pressure From Baseline to 6 Months | Posted | Mean | Standard Deviation | mmHg | Change from Baseline to 6 Months |
|
|
|
| Secondary | Change in Diastolic Blood Pressure From Baseline to 6 Months | Posted | Mean | Standard Deviation | mmHg | Change from Baseline to 6 Months |
|
|
|
| Secondary | Waist Circumference | Posted | Mean | Standard Deviation | inches | Change from Baseline to 6 Months |
|
|
|
| Secondary | LDL Cholesterol | Posted | Mean | Standard Deviation | mg/dl | Change from Baseline to 6 Months |
|
|
|
| Secondary | HDL Cholesterol | Posted | Mean | Standard Deviation | mg/dl | Change from Baseline to 6 Months |
|
|
|
| Secondary | Total Cholesterol | Posted | Mean | Standard Deviation | mg/dl | Change from Baseline to 6 Months |
|
|
|
| Secondary | Triglycerides | Posted | Mean | Standard Deviation | mg/dl | Change from Baseline to 6 Months |
|
|
|
| Secondary | HbA1c | Posted | Mean | Standard Deviation | percent change | Change from Baseline to 6 Months |
|
|
|
| Secondary | Energy Expenditure | percent energy expenditure | Posted | Mean | Standard Deviation | percent expenditure/day | Change from Baseline to 6 Months |
|
|
|
| Secondary | Fiber Intake | Posted | Mean | Standard Deviation | grams per day | Change from Baseline to 6 Months |
|
|
|
| Secondary | Physical Activity (Self-report) | Not Posted | 6 months |
| Secondary | Knowledge & Attitudes About Diabetes Risk | Not Posted | 6 months |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Delayed Intervention | The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |