Changing Lifestyles for Better Health

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848757
• Other study ID #: 0903004817
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: July 2014

Study information

• Verified date: April 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Intensive Lifestyle Intervention
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.

Locations

Country	Name	City	State
United States	Fair Haven Community Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Donaghue Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	The change is weight is reported from baseline to 12 months.	Baseline and 12 Months
Primary	Change in BMI	The change in BMI is reported from baseline to 12 months.	Baseline and 12 Months
Primary	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
Primary	Change in Waist Circumference	Change in waist circumference was measured from baseline to 12 months	Baseline and 12 Months
Primary	Change in Blood Pressure	Change in blood pressure was measured from baseline to 12 months	Baseline and 12 Months
Secondary	Physical Activity Levels (Self-reported)		12 months