Translating the DPP Into the Community

NCT00302042 | Completed Results

• 2 other identifiers: DK70702 (completed)R34DK070702
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  6 months minus baseline

  Baseline, 6 months

Secondary Outcomes (3)

• Physical Activity Level

  Baseline, 6 months

• Rate of Community Program Participation

  Baseline, 6 months

• Change in Dietary Composition

  Baseline, 6 months

Study Arms (2)

1: Brief Counseling Plus Group Lifestyle

EXPERIMENTAL

Brief counseling plus group diabetes prevention in community

Behavioral: Brief counseling plus group diabetes prevention in community

2: Brief Counseling Alone

ACTIVE COMPARATOR

Brief Counseling for pre-diabetes alone

Behavioral: Brief Counseling for pre-diabetes alone

Interventions

Brief counseling plus group diabetes prevention in community 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.

1: Brief Counseling Plus Group Lifestyle

Brief Counseling for pre-diabetes alone 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.

2: Brief Counseling Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• D. Pregnant female E. Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
• A. Unable or unwilling to provide informed consent B. Unable to communicate with the pertinent clinic staff C. Unable to read written English

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Indiana University Diabetes Prevention and Control Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity

Interventions

Residence Characteristics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Ronald T. Ackermann
• Organization: Northwestern University

r.ackermann@northwestern.edu

3126036400

Study Officials

• Ronald T Ackermann, MD, MPH

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ctor, Institute for Public Health and Medicine, Professor of Medicine

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 13, 2006
• Study Start: May 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 18, 2017
• Results First Posted: July 12, 2013

Record last verified: 2014-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)