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

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.

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Group Weight Loss Intervention

Behavioral

Motivational Interviewing

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

Obesity Treatment and NIDDM in Black and White Women

Important dates

Study start: 2000
Study completion: 2002
First posted: Jan 5, 2001
Registry last updated: Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed