Trials / Terminated
TerminatedNCT02741050
Primary Care-Based Physical Activity for Diabetic Latinas
Camino a La Salud: Adapting and Testing a Primary Care-Delivered Physical Activity Intervention for Latinas With Type II Diabetes
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Tailored Physical Activity Intervention | The Tailored Internet intervention is based on constructs of the Transtheoretical Model (TTM) and Social Cognitive Theory (SCT). During the 6-month intervention period, participants will receive monthly mailed questionnaires that assess current motivational readiness for physical activity and other TTM and SCT constructs (e.g., process of change, self-efficacy) and monthly logs to record their current activity. |
| BEHAVIORAL | Standard of Care | Those assigned to the control group will continue to receive standard of care through the Family Medicine clinic. This currently entails commonly accepted medication treatment strategies, educational materials and counseling for self-management and medication adherence, screening for depression or other conditions that would impair self-management, and national and state quality of care guidelines for lab testing and control targets (HbA1c, lipids, blood pressure). Participants in the control group will also receive monthly questionnaires on topics other than physical activity (e.g. diet) to fill out and return in order to have the same opportunities for compensation as those in the intervention condition. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2016-04-18
- Last updated
- 2020-01-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02741050. Inclusion in this directory is not an endorsement.