Fair Haven Community Health Center
New Haven, Connecticut, 06513, United States
NCT Number: NCT00848757
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.
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Notify Me18 year–55 year
Female
Interventional
Not applicable
New Haven, Connecticut, 06513, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In order to be eligible for this study, the following criteria must be met:
Exclusion criteria
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.
Time frame: Baseline and 12 Months
The change is weight is reported from baseline to 12 months.
Time frame: Baseline and 12 Months
The change in BMI is reported from baseline to 12 months.
Time frame: Baseline and 12 Months
Change in percent body fat is reported from baseline to 12 months. Body composition by body fat analyzer (TBF-300; Tanita,Arlington Heights, IL) was used.
Time frame: Baseline and 12 Months
Change in waist circumference was measured from baseline to 12 months
Time frame: Baseline and 12 Months
Change in blood pressure was measured from baseline to 12 months
Time frame: 12 months
Yale University
Other
Changing Lifestyles for Better Health: A Model Program for Community Health Centers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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