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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007800
Recruitment Status : Completed
First Posted : January 5, 2001
Last Update Posted : January 14, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Behavioral: Behavioral Group Weight Loss Intervention Behavioral: Motivational Interviewing Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Obesity Treatment and NIDDM in Black and White Women
Study Start Date : May 2000
Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00007800

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) Identifier: NCT00007800     History of Changes
Obsolete Identifiers: NCT00331266
Other Study ID Numbers: Smith-West (completed)
R01DK054041 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2001    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms