Changing Lifestyles for Better Health

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
William Tamborlane, Yale University
ClinicalTrials.gov Identifier:
NCT00848757
First received: February 18, 2009
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Intensive Lifestyle Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Changing Lifestyles for Better Health: A Model Program for Community Health Centers

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in weight, height, BMI, waist circumference, blood pressure, pulse, percent of body fat between control and intervention groups [ Time Frame: Baseline, 12 weeks and 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical Activity Levels (self-reported) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: March 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Counseling
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.
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.
No Intervention: Usual Care Control
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848757

Locations
United States, Connecticut
Fair Haven Community Health Center Recruiting
New Haven, Connecticut, United States, 06513
Contact: William Tamborlane, MD    203-314-9606    william.tamborlane@yale.edu   
Contact: Kellt Byron    203-7854279    kelly.byron@yale.edu   
Sponsors and Collaborators
Yale University
Donaghue Medical Research Foundation
  More Information

No publications provided

Responsible Party: William Tamborlane, Chief, Pediatric Endocrinology, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00848757     History of Changes
Other Study ID Numbers: Donaghue DF08-313
Study First Received: February 18, 2009
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Diabetes
Lifestyle Intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014