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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity

• Registration Number: NCT00007800
• Lead Sponsor: 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).

Study Timeline

• Study Start: 2000-05
• Study First Submitted QC: 2001-01-04
• Study First Submitted: 2001-01-05
• Study First Posted: 2001-01-05
• Study Completion: 2002-05
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States