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

Obesity Clinical Trial

Official title:

Obesity Treatment and NIDDM in Black and White Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007800
• Other study ID #: Smith-West (completed)
• Secondary ID: RO1 DK 54041
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2001
• Last updated: January 12, 2010
• Start date: May 2000
• Est. completion date: May 2002

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT00331266

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Behavioral Group Weight Loss Intervention

• Motivational Interviewing

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

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

Country where clinical trial is conducted

United States,