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
  Purpose

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.


Condition Intervention Phase
Prediabetic State
Overweight
Obesity
Behavioral: Brief counseling plus group diabetes prevention in community
Behavioral: Brief Counseling for pre-diabetes alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Translating the DPP Into the Community

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 92
Study Start Date: May 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Brief Counseling Plus Group Lifestyle
Brief counseling plus group diabetes prevention in community
Behavioral: Brief counseling plus group diabetes prevention in community
.
Active Comparator: 2: Brief Counseling Alone
Brief Counseling for pre-diabetes alone
Behavioral: Brief Counseling for pre-diabetes alone
.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302042

Locations
United States, Indiana
Indiana University Diabetes Prevention and Control Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Ronald T Ackermann, MD, MPH Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: RAckermann, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00302042     History of Changes
Other Study ID Numbers: DK70702 (completed), R34DK070702
Study First Received: March 10, 2006
Results First Received: May 23, 2013
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Obesity
Prediabetic State
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014