Changing Lifestyles for Better Health

NCT00848757 | Completed Results

• 1 other identifier: 0903004817
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Lifestyle Intervention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Physical Activity Levels (Self-reported)

  12 months

Study Arms (2)

Intensive Life-Style Counseling

EXPERIMENTAL

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

Usual Care Control

NO INTERVENTION

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.

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

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.

Intensive Life-Style Counseling

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Donaghue Medical Research Foundation: collaborator

Study Sites (1)

Fair Haven Community Health Center

New Haven, Connecticut, 06513, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Michelle Van Name
• Organization: Yale University School of Medicine

michelle.vanname@yale.edu

203-785-5831

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 20, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 4, 2022
• Results First Posted: March 17, 2022

Record last verified: 2022-04

Locations

US (1)