Clinical trial NCT00848757: Changing Lifestyles for Better Health
Official title: Changing Lifestyles for Better Health: A Model Program for Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Lifestyle Intervention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Donaghue Medical Research Foundation
First posted: 2009-02-20
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style intervention (ILI) program that has been developed and implemented at the FHCHC to prevent the development of diabetes.

Detailed description: This project is a clinical outcome study that merges the expertise of a senior Yale clinical investigator, the clinical and translational research resources of YCCI, the clinical and community expertise of the FHCHC Diabetes Team, and the high-need patient population of FHCHC. In addition to determining the efficacy and cost-effectiveness of an ILI for diabetes prevention in an inner-city community health center setting, this project will evaluate the effectiveness of pooling academic expertise with direct clinical services to disadvantaged, at-risk populations.

Eligibility criteria: Inclusion Criteria:

In order to be eligible for this study, the following criteria must be met:

* Subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ILI (the John Martinez School).
* Subjects must have had a 2 hour 75 gram Oral Glucose Tolerance Test (OGTT) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
* Willingness to undergo fasting blood testing: HOMA-IR, fasting lipid profile (including total cholesterol, HDL, LDL cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the OGTT) and repeated at 12 months.
* Subjects must have no medical contraindications to exercise or dieting.

Exclusion Criteria:

* Subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ILI program.
* Subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
* Women who are pregnant or planning to become pregnant will not be enrolled in this study.
* Any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
* Subjects cannot participate if they have concurrent membership in a comprehensive weight management program.

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline and 12 Months
measure: Change in BMI
timeFrame: Baseline and 12 Months
measure: Change in Percent Body Fat
timeFrame: Baseline and 12 Months
measure: Change in Waist Circumference
timeFrame: Baseline and 12 Months
measure: Change in Blood Pressure
timeFrame: Baseline and 12 Months
Secondary outcomes:
measure: Physical Activity Levels (Self-reported)
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Fair Haven Community Health Center
state: Connecticut
Study officials:
References: