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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Behavioral: Behavioral Group Weight Loss Intervention; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: NIH

Identifiers

NCT00007800

R01DK054041 (U.S. NIH Grant/Contract)

Smith-West (completed)

Details and patient eligibility

About

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.

Full 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).

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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