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Home > "N" Clinical Trials Conditions > NEW DAY: Nutrition, Exercise, Weight loss, Diabetes And You  NEW DAY: Nutrition, Exercise, Weight loss, Diabetes And You
NEW DAY: Nutrition, Exercise, Weight loss, Diabetes And You
For Condition: Obesity,Diabetes Mellitus, Type 2
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Parallel Assignment
Minimum Age/Maximum Age: 19 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 218
Location and Contact Information:
University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
Additional Information:
Study ID Numbers: Smith-West; RO1 DK 54041
Study Start Date: May 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007800
Other Diabetes Mellitus, Type 2 Studies:
1. Prevention of Type 2 Diabetes Mellitus in Children
2. Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
3. Improving Medication Adherence in Co morbid Conditions
4. Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
5. Computer-assisted diabetes self-management interventions
Related Studies:
Other Diabetes Mellitus, Type 2 Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
NEW DAY: Nutrition, Exercise, Weight loss, Diabetes And You
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