N/A
N=130
Changing Lifestyles for Better Health
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00848757 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change in Weight — -3.8; 1.4 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensive Lifestyle Intervention (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
-3.8; 1.4 | — |
| PRIMARY Change in BMI |
-1.6; 0.6 | — |
| PRIMARY Change in Percent Body Fat |
-1.9; 0.4 | — |
| PRIMARY Change in Waist Circumference |
-3.3; -0.2 | — |
| PRIMARY Change in Blood Pressure |
-1.5; 0; -0.5; -0.9 | — |
| SECONDARY Physical Activity Levels (Self-reported) |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00848757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.