NEW DAY: Nutrition, Exercise, Weight Loss, Diabetes And You - Tabular View

Tracking Information
First Received Date ^ICMJE	January 5, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	May 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00007800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	NEW DAY: Nutrition, Exercise, Weight Loss, Diabetes And You
Official Title ^ICMJE	Obesity Treatment and NIDDM in Black and White Women
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.
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Parallel Assignment
Condition ^ICMJE	Diabetes Mellitus, Type 2 Obesity
Intervention ^ICMJE	Behavioral: Behavioral Group Weight Loss Intervention Behavioral: Motivational Interviewing
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	218
Completion Date	May 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	19 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00007800
Responsible Party
Study ID Numbers ^ICMJE	Smith-West, RO1 DK 54041
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	May 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP