Clinical trial NCT02741050: Primary Care-Based Physical Activity for Diabetic Latinas
Official title: Camino a La Salud: Adapting and Testing a Primary Care-Delivered Physical Activity Intervention for Latinas With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Sedentary Lifestyle
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this proposal is to test the efficacy of a primary care-delivered, print-based physical activity intervention for Latinas with type II diabetes. The investigators will test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited through UCSD Health System primary care to either the adapted web-based physical activity intervention or standard of care, and assessing physical activity gains at six and 12 months. The ultimate goal is to develop a print-based physical activity intervention for diabetic Latinas that could be widely disseminated through primary care.

Detailed description: Studies show that adoption of regular physical activity (PA) can greatly enhance diabetes management and prevention. Individuals who adopt a PA routine show significant improvements in clinical markers of diabetes, including HbA1c, glucose tolerance, insulin sensitivity, weight and waist circumference, and significant reductions in medication use, and also show reductions in cardiovascular risk factors and other related co-morbidities. Incorporation of cost-effective PA interventions into primary care for diabetes treatment could therefore enhance overall health and quality of life and significantly reduce healthcare costs. The primary aim of this study is to conduct a small randomized trial (N=80) to test the efficacy of an individually tailored culturally adapted print-based physical activity intervention integrated into primary care to increase weekly moderate-to-vigorous physical activity in Latinas with type II diabetes, compared to those receiving standard of care.

Eligibility criteria: Inclusion Criteria:

* Have received a physician's diagnosis of type II diabetes and are currently being seen by a primary care physician
* Currently inactive, defined as participating in at least moderate intensity physical activity for less than 60 minutes per week

Exclusion Criteria:

* Medical condition that may make exercise unsafe, including congestive heart failure, severe musculoskeletal problems or pulmonary conditions, or other conditions determined by the referring physician to preclude unsupervised exercise
* Unable to receive mailed materials (do not have a mailing address)
* Unable to engage in physical activity for at least 30 minutes
* Have a current or planned pregnancy
* Planning to move from the area within the next year

Primary outcomes:
measure: Objective Changes in Physical Activity from Baseline to 6 Months
timeFrame: Baseline, 6 Months (MO)
measure: Self-Report Changes in Physical Activity from Baseline to 6 Months
timeFrame: Baseline, 6 Months (MO)
Secondary outcomes:
measure: Objective Changes in Physical Activity from 6 Months to 12 Months
timeFrame: 6 Months (MO), 12 Months (MO)
measure: Self-Report Changes in Physical Activity from 6 Months to 12 Months
timeFrame: 6 Months (MO), 12 Months (MO)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UC, San Diego Department of Family Medicine and Public Health
name: Britta Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: