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Clinical Trials/NCT00770926
NCT00770926
Completed
Not Applicable

Physical Activity and Diet to to Reduce Disparities in Diabetes Risk

University of California, San Francisco1 site in 1 country230 target enrollmentSeptember 2006
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of California, San Francisco
Enrollment
230
Locations
1
Primary Endpoint
Body weight
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Body weight

Time Frame: one year

Secondary Outcomes

  • diet(One year)

Study Sites (1)

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