Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings (LWBW)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Live Well, Be Well

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00770926

R18DK067896 (U.S. NIH Grant/Contract)

R18DK067896-01A2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Program immediately

Experimental group

Description:

Receives the lifestyle program as soon as possible after randomization

Treatment:

Behavioral: Live Well, Be Well

Wait list control

No Intervention group

Description:

Wait one year and at the end of the year, is offered the option of participating in the program