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Clinical Trials/NCT00302042
NCT00302042
Completed
Not Applicable

Translating the DPP Into the Community

Northwestern University1 site in 1 country92 target enrollmentMay 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prediabetic State
Sponsor
Northwestern University
Enrollment
92
Locations
1
Primary Endpoint
Change in Weight
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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 Young Mens Christian Association (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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
August 2007
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ronald Ackermann

ctor, Institute for Public Health and Medicine, Professor of Medicine

Northwestern University

Eligibility Criteria

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:
  • A "Yes" response to any item on the modified Physical Activity Readiness Questionnaire (see Appendix 2)
  • Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg
  • Heart attack, stroke, or transient ischemic attack in the past 6 months, C. Lung disease: Chronic obstructive airways disease or asthma requiring home oxygen
  • 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

Outcomes

Primary Outcomes

Change in Weight

Time Frame: Baseline, 6 months

6 months minus baseline

Secondary Outcomes

  • Physical Activity Level(Baseline, 6 months)
  • Change in Dietary Composition(Baseline, 6 months)
  • Rate of Community Program Participation(Baseline, 6 months)

Study Sites (1)

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