Changing Lifestyles for Better Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Changing Lifestyles for Better Health: A Model Program for Community Health Centers

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Intensive Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Life-Style Counseling<br>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 Diabetes Prevention Program (DPP) Lifestyle Balance program, but modified for a group format and to be more culturally and linguistically appropriate for this population. | Behavioral: Intensive Lifestyle Intervention<br>* 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.<br>|
| No Intervention: Usual Care Control<br>Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | The change is weight is reported from baseline to 12 months. | Baseline and 12 Months | 
| Change in BMI | The change in BMI is reported from baseline to 12 months. | Baseline and 12 Months | 
| Change in Percent Body Fat | 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. | Baseline and 12 Months | 
| Change in Waist Circumference | Change in waist circumference was measured from baseline to 12 months | Baseline and 12 Months | 
| Change in Blood Pressure | Change in blood pressure was measured from baseline to 12 months | Baseline and 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Levels (Self-reported) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Lifestyle Intervention