August 1, 2008 |
August 5, 2008 |
August 2008 |
The primary outcome measure is weight loss with a goal of 7% of initial weight. [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00729079 on ClinicalTrials.gov Archive Site |
- Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- ;Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day;Fasting blood sugar < 100 mg/dL; Absence of
tobacco use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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Same as current |
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Diabetes Prevention Program Pilot Study |
Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study |
This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care). |
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Interventional |
Prevention, Randomized, Open Label, Parallel Assignment |
Diabetes Prevention |
Behavioral: DPP |
- Active Comparator: Subject will be randomly assigned to work with providers at Clinton Medical Associates
- Active Comparator: Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125
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- American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. No abstract available.
- Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9.
- Goldstein MG, Whitlock EP, DePue J; Planning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project. Multiple behavioral risk factor interventions in primary care. Summary of research evidence. Am J Prev Med. 2004 Aug;27(2 Suppl):61-79. Review.
- Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE; Diabetes Prevention Program Research Group. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005 Mar 1;142(5):323-32.
- Maciosek MV, Edwards NM, Coffield AB, Flottemesch TJ, Nelson WW, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: methods. Am J Prev Med. 2006 Jul;31(1):90-6. Review.
- 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.
- Westfall JM, Mold J, Fagnan L. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403-6. No abstract available.
- Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26.
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Not yet recruiting |
80 |
August 2009 |
August 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Age >18 years
- BMI >24 kg/m2 (>22 kg/m2 among Asian Americans)
- IGT (2-h plasma glucose 140~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
- Elevated FPG (95~125 mg/dl*).
- HDL-triglyceride ration > 3.5.
Exclusion Criteria:
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Both |
18 Years to 90 Years |
Yes |
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United States |
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NCT00729079 |
Geoffrey C Williams, MD PhD, University of Rochester |
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University of Rochester |
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Principal Investigator: |
Geoffrey C Williams, MD, PhD |
University ofRochester |
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Principal Investigator: |
Heather Patrick, PhD |
University of Rochester |
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University of Rochester |
August 2008 |