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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00770926
First received: October 8, 2008
Last updated: May 19, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
 Behavioral: Live Well, Be Well

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Physical Activity and Diet to to Reduce Disparities in Diabetes Risk

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Body weight [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diet [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: September 2006
Study Completion Date: May 2013
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Program immediately
Receives the lifestyle program as soon as possible after randomization
 Behavioral: Live Well, Be Well
Lifestyle change program using personal contact and telephone counseling
No Intervention: Wait list control
Wait one year and at the end of the year, is offered the option of participating in the program

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770926

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Anita L Stewart, Ph.D University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00770926     History of Changes
Other Study ID Numbers: R18 DK067896-01A2, R18DK067896
Study First Received: October 8, 2008
Last Updated: May 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
risk reduction
minority
diabetes prevention
lifestyle program
behavior change

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013