NCT00007800

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

Obesity Treatment and NIDDM in Black and White Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (planned)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetes Mellitus, Type 2
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Group Weight Loss Intervention
BEHAVIORAL	Motivational Interviewing

Timeline

• Start date: 2000-05-01
• Completion: 2002-05-01
• First posted: 2001-01-05
• Last updated: 2010-01-14

Locations

1 site across 1 country: United States