Translating the DPP Into the Community

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RAckermann, Northwestern University
ClinicalTrials.gov Identifier:
NCT00302042
First received: March 10, 2006
Last updated: May 23, 2013
Last verified: May 2013

March 10, 2006
May 23, 2013
May 2005
August 2007   (final data collection date for primary outcome measure)
Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00302042 on ClinicalTrials.gov Archive Site
  • Physical Activity Level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Rate of Community Program Participation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Dietary Composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Translating the DPP Into the Community
Translating the DPP Into the Community

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 (Young Mens Christian Association) 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Prediabetic State
  • Overweight
  • Obesity
  • Behavioral: Brief counseling plus group diabetes prevention in community
    .
  • Behavioral: Brief Counseling for pre-diabetes alone
    .
  • Experimental: 1: Brief Counseling Plus Group Lifestyle
    Brief counseling plus group diabetes prevention in community
    Intervention: Behavioral: Brief counseling plus group diabetes prevention in community
  • Active Comparator: 2: Brief Counseling Alone
    Brief Counseling for pre-diabetes alone
    Intervention: Behavioral: Brief Counseling for pre-diabetes alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
August 2007
August 2007   (final data collection date for primary outcome measure)

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:

  1. A "Yes" response to any item on the modified Physical Activity Readiness Questionnaire (see Appendix 2)
  2. Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
  3. 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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00302042
DK70702 (completed), R34DK070702
No
RAckermann, Northwestern University
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Ronald T Ackermann, MD, MPH Indiana University School of Medicine
Northwestern University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP