Changing Lifestyles for Better Health

Completed · Not applicable

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00848757

Run by

Yale University

People needed

130

Starts

2009-03-01

Expected to finish

2014-07-01

Last updated by the study team

2022-05-04

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fair Haven Community Health Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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