NEW DAY: Nutrition, Exercise, Weight Loss, Diabetes And You

Obesity Treatment and NIDDM in Black and White Women

Sponsors

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brief Summary

This clinical trial examines whether the addition of individual sessions of a motivational intervention to a state-of-the art behavioral group weight loss intervention for overweight women with Type 2 diabetes improves the weight losses and glycemic control outcomes.

Detailed Description

The multi-disciplinary behavioral, group-based intervention focuses on dietary and exercise changes, with group meetings over an 18-month period. Participants are assessed at 6-month intervals (for a total of 18 months) to examine the impact of the interventions on body weight and blood sugar control (primary outcomes), as well as on blood pressure, cholesterol, quality of life and attitudes (secondary outcomes). All enrolled participants receive group-based weight loss intervention. Half the women enrolled also receive several individual sessions of motivational interviewing and the other half of enrolled women receive the same number of individual sessions of health education, which focus on issues relevant to women (e.g., mammography, sleep hygiene, menopause, etc).

Overall Status Completed
Start Date May 2000
Completion Date May 2002
Phase Phase 2
Study Type Interventional
Enrollment 218
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Behavioral Group Weight Loss Intervention

Intervention Type: Behavioral

Intervention Name: Motivational Interviewing

Eligibility

Criteria:

Inclusion Criteria:

- Body Mass Index of 27 - 50

- Type 2 diabetes currently treated with oral medications

- Ability to walk for exercise

Exclusion Criteria:

- Use of insulin

- Current pregnancy

- Presence of debilitating disease, psychotic condition or any other condition that might interfere with participation

- Failure to complete self monitoring diary for 1 week

- Plans to move out of the area in the upcoming 18 months

Gender: Female

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: University of Alabama at Birmingham
Location Countries

United States

Verification Date

January 2010

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Source: ClinicalTrials.gov