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Translating the DPP Into the Community

Primary Purpose

Prediabetic State, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief counseling plus group diabetes prevention in community
Brief Counseling for pre-diabetes alone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Diabetes Prevention and Control Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: Brief Counseling Plus Group Lifestyle

2: Brief Counseling Alone

Arm Description

Brief counseling plus group diabetes prevention in community

Brief Counseling for pre-diabetes alone

Outcomes

Primary Outcome Measures

Change in Weight
6 months minus baseline

Secondary Outcome Measures

Physical Activity Level
Rate of Community Program Participation
Change in Dietary Composition

Full Information

First Posted
March 10, 2006
Last Updated
June 20, 2017
Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00302042
Brief Title
Translating the DPP Into the Community
Official Title
Translating the DPP Into the Community
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Brief Counseling Plus Group Lifestyle
Arm Type
Experimental
Arm Description
Brief counseling plus group diabetes prevention in community
Arm Title
2: Brief Counseling Alone
Arm Type
Active Comparator
Arm Description
Brief Counseling for pre-diabetes alone
Intervention Type
Behavioral
Intervention Name(s)
Brief counseling plus group diabetes prevention in community
Intervention Description
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
Intervention Name(s)
Brief Counseling for pre-diabetes alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Weight
Description
6 months minus baseline
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Physical Activity Level
Time Frame
Baseline, 6 months
Title
Rate of Community Program Participation
Time Frame
Baseline, 6 months
Title
Change in Dietary Composition
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald T Ackermann, MD, MPH
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Diabetes Prevention and Control Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Translating the DPP Into the Community

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