Clinical trial NCT00770926: Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings
Official title: Physical Activity and Diet to to Reduce Disparities in Diabetes Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: risk reduction
minority
diabetes prevention
lifestyle program
behavior change
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-10-10
Enrollment: 230
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

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.

Primary outcomes:
measure: Body weight
timeFrame: one year
Secondary outcomes:
measure: diet
timeFrame: One year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anita L Stewart, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1177/0145721710374368. Epub 2010 Jun 24.
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 program. Gerontologist. 2011 Jun;51 Suppl 1(Suppl 1):S82-93. doi: 10.1093/geront/gnr026.