Clinical Trials Logo

Clinical Trial Summary

In this study, investigators are specifically targeting Latina women as they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions such as obesity, diabetes, or cardiovascular disease. The objective of Pasos Hacia La Salud is to test a Spanish-language Internet-based Physical Activity Intervention, in comparison to a Spanish-language Internet-based Wellness Contact Control condition. Participants are randomly assigned to one of two groups (Exercise and General Wellness). The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants.


Clinical Trial Description

In the U.S., Latino women (Latinas) report higher rates of inactivity than their non-Hispanic White and male counterparts and thus are disproportionately burdened by related health conditions (e.g., cancer, hypertension, heart disease, stroke, diabetes). Cultural factors, socioeconomic circumstances, language and educational barriers limit Latinas access to public health interventions that promote physically active lifestyles. To address this public health crisis, effective interventions that leverage state-of-the-art theory and methods are needed to reach this at-risk population. Our research group has over 20 years experience developing and evaluating individually-tailored, computer expert system-driven, physical activity interventions (based on Social Cognitive Theory and the Transtheoretical Model) through various channels and settings. In our recent pilot (R21NR009864), we culturally and linguistically adapted our tailored intervention for sedentary Latinas and conducted a small randomized trial of the modified program (N=93). A total of 81 participants completed the 6-month study (87% retention) and increased their physical activity from a mean of 17 minutes per week (SD=25.76) at baseline to 147 minutes (SD=241.55) at six months whereas contact control participants increased their physical activity from 12 minutes per week (SD=21.99) at baseline to 97 minutes (SD=118.49) at six months. These observed improvements in physical activity in our intervention group, along with high retention rates, participant-reported desire for an Internet-delivered program, and formative work developing our program in an Internet format lend support for testing an Internet intervention tailored to the needs of Latinas. Therefore, for the current proposal, we will build on our previous work by conducting an adequately powered (N=200) randomized controlled trial to test the efficacy of our culturally and linguistically modified, individually tailored physical activity intervention delivered via the Internet relative to an Internet wellness contact control condition (including cardiovascular health information developed for Latinos by the NHLBI). Data will be collected at baseline, 6 months (post-treatment), and 12 months (maintenance) using well-established physical activity measures (7-Day PAR, Actigraphs), as well as a comprehensive set of psychosocial questionnaires. We hypothesize that at end of treatment (month six) intervention participants will report significantly more minutes of moderate intensity physical activity per week than the wellness contact control participants. We will also examine the maintenance of treatment effects at 12 months, potential mediators and moderators of the intervention-physical activity relationship, and the costs of delivering the tailored Internet program. In the proposed study we seek to promote physical activity among an underserved population using a high-reach, low-cost, technology-based strategy, which has great potential for adoption on a larger scale and thus high potential for reducing health disparities in the U.S. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01834287
Study type Interventional
Source University of California, San Diego
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date March 2015

See also
  Status Clinical Trial Phase
Completed NCT00724165 - Seamos Activas: Increasing Physical Activity Among Latinas Phase 2
Completed NCT03803085 - A Group-Based Walking Study Using WeChat to Enhance Physical Activity Among Older Adults N/A
Completed NCT01690728 - Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass N/A
Completed NCT02080585 - Effectiveness of a Web-based, Computer-tailored, Pedometer-based Physical Activity Intervention for Adults: a Cluster-randomized Controlled Trial N/A
Completed NCT00899964 - IT-based Training in Obesity N/A
Terminated NCT03751449 - Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors N/A
Completed NCT03491592 - Web-based Physical Activity Intervention for Latinas N/A
Completed NCT02512419 - Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men N/A
Completed NCT00607009 - Project ALIVE (A Lifestyle Intervention Via Email) N/A
Completed NCT01828229 - Consequences of Human Inactivity N/A
Completed NCT00967460 - Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity and Quality of Life of Children in Childcare Settings N/A
Completed NCT00260117 - Long-Term Exercise Maintenance Via Internet Support Phase 1/Phase 2
Recruiting NCT03798873 - Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35 N/A
Completed NCT02630953 - Culturally and Linguistically Adapted Physical Activity Intervention for Latinas N/A
Not yet recruiting NCT00954694 - Analysis of the NuStep as an Introductory Fitness Regimen N/A
Completed NCT01173978 - Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance N/A
Completed NCT00473044 - An Intervention to Increase Physical Activity Among African American Women N/A