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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00007800
First received: January 5, 2001
Last updated: January 12, 2010
Last verified: January 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Obesity Treatment and NIDDM in Black and White Women

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00007800     History of Changes
Obsolete Identifiers: NCT00331266
Other Study ID Numbers: Smith-West (completed), RO1 DK 54041
Study First Received: January 5, 2001
Last Updated: January 12, 2010
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

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

ClinicalTrials.gov processed this record on July 26, 2014