Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Live Well, Be Well

• Registration Number: NCT00770926
• Lead Sponsor: University of California, San Francisco

Brief Summary

This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on reaching lower-income, minority individuals.

Detailed Description

To design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, to increase physical activity, decrease weight, and improve diet, offered in community-based settings to primarily lower income, minority persons aged 25 and older at moderate to high risk of diabetes. The design is a randomized controlled trial with the primary outcome being fasting plasma glucose; secondary outcomes are weight, physical activity, blood pressure, and other physiological risk factors as well as health-related quality of life. This project is a partnership between the University of California San Francisco and the City of Berkeley Division of Public Health.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-10
• Primary Completion: 2009-08
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-19
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• age 25 and older
• moderate- to high-risk score on a Diabetes Risk Appraisal (DRA) (assessing sedentary behavior, family history of diabetes, race/ethnicity, gestational diabetes, hypertension, and high cholesterol) and a fasting fingerstick glucose level of 95-140 mg/dL (indicating high risk of diabetes).
• conversant in English or Spanish

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Exclusion Criteria

1. diabetes, assessed by self-report of having ever been told by a physician that they have diabetes (other than gestational) OR use of an oral hypoglycemic medication or insulin, OR a fingerstick fasting glucose level of >150 mg/dl;
2. unstable chronic or serious condition that could limit participation in unsupervised light to moderate physical activity (e.g. unstable angina, diagnosed with or hospitalized for chest pain, heart surgery, stroke, or myocardial infarction in the past 6 months);
3. uncontrolled hypertension (systolic >180 mmHg or diastolic >105 mmHg);
4. current pregnancy or attempting to conceive;
5. plans to move from the area within 1 year;
6. insufficient cognitive functioning to complete program procedures,
7. implanted defibrillator,
8. a hip or knee replacement in the past 3 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Program immediately	Live Well, Be Well	Receives the lifestyle program as soon as possible after randomization

Primary Outcome Measures

Name	Time	Method
Body weight	one year

Secondary Outcome Measures

Name	Time	Method
diet	One year

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States