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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00302042 |
The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type 2 diabetes in those at increased risk for the disease. The lifestyle program used, however, was not designed for delivery on a public health scale. Successful community translation of the DPP's findings will require close collaboration with an established community organization committed to improving community health and experienced in implementing sustainable health and wellness programs. With exceptional reach into diverse U.S. communities, the YMCA may be an ideal community partner. We have been collaborating with the YMCA organization for over a year to design a robust recruitment and implementation model that is sensitive to the unique needs and resources of a community organization. We now propose to evaluate if a group-based adaptation of the DPP lifestyle intervention can be successfully implemented by YMCA staff, in YMCA facilities. We have designed this study to develop preliminary data about the reach, effectiveness, and consistent implementation of the DPP lifestyle intervention in this context. This pilot study has two primary aims: 1) to demonstrate the extent to which YMCA staff trained by DPP study personnel can administer a group-based adaptation of the DPP lifestyle intervention in a fashion consistent with DPP intervention protocols, and 2) to evaluate if the intervention program delivered by the YMCA results in changes in body mass, physical activity, and dietary intake that are consistent with a level found to be associated with diabetes risk reduction during the DPP trial. We will also collect valuable data about the feasibility and reach of a selective, community-based marketing and screening approach for recruiting program participants. In combination, these data will enable us to design and conduct a larger, future 3-year trial focusing on the effectiveness and sustainability of community DPP translation in multiple YMCA settings.
Condition | Intervention | Phase |
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Prediabetic State Overweight Obesity |
Behavioral: Pre-diabetes assessment and general advice about lifestyle based strategies to prevent type 2 diabetes Behavioral: Pre-diabetes assessment, brief advice, and access to a group-based diabetes prevention lifestyle intervention at the YMCA |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Translating the DPP Into the Community: The YMCA Model |
Enrollment: | 92 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention at the YMCA
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Behavioral: Pre-diabetes assessment, brief advice, and access to a group-based diabetes prevention lifestyle intervention at the YMCA
Pre-diabetes risk assessment, education, and counseling offered at baseline, 6, 12-months. 16-visit lifestyle intervention program occuring for 1 hour every 7-10 days for first 5 months, followed by monthly 90 minute maintenance meetings at YMCA
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2: Active Comparator
Brief Counseling for pre-diabetes alone
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Behavioral: Pre-diabetes assessment and general advice about lifestyle based strategies to prevent type 2 diabetes
Pre-diabetes risk assessment with brief education and counseling performed by School of Medicine partners at the YMCA and repeated after 6 and 12 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
i. 18 years of age or older ii. Body-mass index of >= 24 kg/m2 iii. ADA diabetes risk assessment score >= 10 (see below) iv. Casual capillary blood glucose >= 110 mg/dl
Exclusion Criteria:
i. Exclusions for diseases likely to limit life span and/or increase risk of interventions:
A. Cancer requiring treatment in the past 5 years
B. Cardiovascular disease:
ii. Exclusions related to metabolism: A. Diabetes at baseline evaluation B. Casual capillary blood glucose >= 200 mg/dl C. History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
D. Pregnant female E. Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
iii. Exclusion for conditions or behaviors likely to affect the conduct of the study:
A. Unable or unwilling to provide informed consent B. Unable to communicate with the pertinent clinic staff C. Unable to read written English
United States, Indiana | |
Indiana University Diabetes Prevention and Control Center | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Ronald T Ackermann, MD, MPH | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( Ronald T. Ackermann, MD, MPH ) |
Study ID Numbers: | DK70702, DK70702 |
Study First Received: | March 10, 2006 |
Last Updated: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00302042 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Obesity Metabolic Diseases Prediabetic State Diabetes Mellitus Endocrine System Diseases Overweight Body Weight |
Signs and Symptoms Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |