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

This study has been completed.

First Received: January 5, 2001 Last Updated: June 23, 2005 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00007800

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Obesity	Behavioral: Behavioral Group Weight Loss Intervention Behavioral: Motivational Interviewing	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Parallel Assignment
Official Title:	Obesity Treatment and NIDDM in Black and White Women

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity Weight Control

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	218
Study Start Date:	May 2000
Estimated Study Completion Date:	May 2002

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).

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007800

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205

Sponsors and Collaborators

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

More Information

No publications provided

Study ID Numbers:	Smith-West, RO1 DK 54041
Study First Received:	January 5, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00007800 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

obesity treatment
non insulin dependent diabetes
type 2 diabetes

behavioral weight control
motivational interviewing
motivational enhancement

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Hydroquinone
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Weight Loss
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009