Clinical trial NCT00302042: Translating the DPP Into the Community
Official title: Translating the DPP Into the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Overweight
Obesity
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-03-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Physical Activity Level
timeFrame: Baseline, 6 months
measure: Rate of Community Program Participation
timeFrame: Baseline, 6 months
measure: Change in Dietary Composition
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Diabetes Prevention and Control Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Ronald T Ackermann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: