Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings

Diabetes Clinical Trial

— LWBW  

Official title:

Physical Activity and Diet to to Reduce Disparities in Diabetes Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770926
• Other study ID #: R18DK067896-01A2
• Secondary ID: R18DK067896
• Status: Completed
• Phase: N/A
• First received: October 8, 2008
• Last updated: May 19, 2013
• Start date: September 2006
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: May 2013
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Live Well, Be Well
Lifestyle change program using personal contact and telephone counseling

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Delgadillo AT, Grossman M, Santoyo-Olsson J, Gallegos-Jackson E, Kanaya AM, Stewart AL. Description of an academic community partnership lifestyle program for lower income minority adults at risk for diabetes. Diabetes Educ. 2010 Jul-Aug;36(4):640-50. doi — View Citation

Santoyo-Olsson J, Cabrera J, Freyre R, Grossman M, Alvarez N, Mathur D, Guerrero M, Delgadillo AT, Kanaya AM, Stewart AL. An innovative multiphased strategy to recruit underserved adults into a randomized trial of a community-based diabetes risk reduction — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		one year	No
Secondary	diet		One year	No