At a glance
ClinicalIndex Comparison Record- ✓Fasting glucose 100-126 mg/dL OR 2-hour glucose 140-200 mg/dL on 75-gram OGTT within 4 months prior to enrollment
- ✓Willing and able to travel to clinic for all regularly scheduled study visits and to the ILI program site (John Martinez School)
- ✓Willing to undergo fasting blood testing at baseline and 12 months (HOMA-IR, lipid panel)
- ✓No medical contraindications to exercise or dieting
- ✕Diagnosis of diabetes mellitus
- ✕Serious medical or psychiatric condition that would preclude participation in the ILI program
- ✕Taking medications that cause significant weight gain or loss (prescription, over-the-counter, or herbal supplements)
- ✕Pregnant or planning to become pregnant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Changing Lifestyles for Better Health: A Model Program for Community Health Centers
In Brief
A clinical study evaluating Intensive Lifestyle Intervention for Type 2 Diabetes Mellitus. Completed, enrolled 130 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Women with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.