Translating the DPP Into the Community

NCT ID: NCT00302042

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-08-31

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.

Conditions

Prediabetic State; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1: Brief Counseling Plus Group Lifestyle

Brief counseling plus group diabetes prevention in community

Group Type: EXPERIMENTAL

Brief counseling plus group diabetes prevention in community

Intervention Type: BEHAVIORAL

Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk, Group diabetes prevention in community: 16 weekly group lifestyle behavior change visits followed by monthly group lifestyle behavior change visits.

2: Brief Counseling Alone

Brief Counseling for pre-diabetes alone

Group Type: ACTIVE_COMPARATOR

Brief Counseling for pre-diabetes alone

Intervention Type: BEHAVIORAL

Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk.

Interventions

Brief counseling plus group diabetes prevention in community

Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk, Group diabetes prevention in community: 16 weekly group lifestyle behavior change visits followed by monthly group lifestyle behavior change visits.

Intervention Type: BEHAVIORAL

Brief Counseling for pre-diabetes alone

Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk.

Intervention Type: BEHAVIORAL

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Ronald Ackermann

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald T Ackermann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Diabetes Prevention and Control Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

R34DK070702

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK70702 (completed)

Identifier Type: -

Identifier Source: org_study_id