Changing Lifestyles for Better Health

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.

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.