Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical Activity and Diet to to Reduce Disparities in Diabetes Risk

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Live Well, Be Well


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: 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; 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); uncontrolled hypertension (systolic >180 mmHg or diastolic >105 mmHg); current pregnancy or attempting to conceive; plans to move from the area within 1 year; insufficient cognitive functioning to complete program procedures, implanted defibrillator, a hip or knee replacement in the past 3 months.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Program immediately<br>Receives the lifestyle program as soon as possible after randomization | Behavioral: Live Well, Be Well<br>* Lifestyle change program using personal contact and telephone counseling<br>|
| No Intervention: Wait list control<br>Wait one year and at the end of the year, is offered the option of participating in the program | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diet |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk reduction, minority, diabetes prevention, lifestyle program, behavior change