Primary Care-Based Physical Activity for Diabetic Latinas

University of California San Diego

Status: Terminated

Conditions: Diabetes; Sedentary Lifestyle

Treatments: Behavioral: Standard of Care; Behavioral: Tailored Physical Activity Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02741050

K01DK101650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Tailored Physical Activity Intervention

Experimental group

Description:

Intervention group will receive Spanish-language physical activity print intervention based on SCT and Transtheoretical Model, (TTM) that emphasizes behavioral strategies for increasing activity levels.

Treatment:

Behavioral: Tailored Physical Activity Intervention

Standard of Care Control Group

Active Comparator group

Description:

Control group will receive standard of care through the Family Medicine clinic as well as monthly questionnaires on topics other than physical activity (e.g. diet) to complete.

Treatment:

Behavioral: Standard of Care