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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2002-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Diabetes Mellitus, Type 2 Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Behavioral Group Weight Loss Intervention

Intervention Type BEHAVIORAL

Motivational Interviewing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No