Promoting Physical Activity in Churchgoing Latinas
This study is currently recruiting participants.
Verified January 2013 by San Diego State University
Sponsor:
San Diego State University
Collaborator:
Information provided by (Responsible Party):
Elva Arredondo, San Diego State University
ClinicalTrials.gov Identifier:
NCT01776632
First received: October 29, 2012
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. The goals of the current study, based largely upon the core principles of the Social Ecological Model, are to design, implement, and evaluate an innovative multi-level intervention promoting physical activity among churchgoing Latinas.
The evidenced-based intervention targets three "tiers" of environmental influences (i.e., church, immediate neighborhood surrounding the church, and community) on activity, as well as MVPA-related personal factors (i.e.., intra/interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer prevention and control via screening.
Sixteen churches will be randomly assigned to either the physical activity intervention or the attention-control condition. The primary aim of the study is to determine whether a multi-level intervention will increase MVPA among Latina churchgoers in the intervention condition relative to the attention-control condition.
| Condition | Intervention |
|---|---|
|
Chronic Disease |
Behavioral: Physical activity Behavioral: Cancer prevention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action) |
Resource links provided by NLM:
Further study details as provided by San Diego State University:
Primary Outcome Measures:
- Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer and self-report [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Body Mass Index [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]
- Change in Waist Circumference [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]
- Change in Cardiovascular Fitness Level [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]Submaximal Step Test
- Change in Intrapersonal Mediators of PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]The current study examines the following potential mediators of PA: self-efficacy for being physically active; benefits to PA; enjoyment of PA; and barriers to PA via self-report survey items.
- Change in Interpersonal Mediators of PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]The current study examines social support for PA via self-report survey items.
- Change in Environmental Mediators of PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]The current study examines the following environmental mediators of PA including perceived environment via self-report, as well as Geographic Information Systems (GIS) and direct observational measures of built environment changes targeted in the intervention.
- Change in Potential Cultural Moderators on Latinas' PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]The current study examines the moderating influence of factors that characterize the Latino culture (religious beliefs, acculturation and demographics).
| Estimated Enrollment: | 464 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Physical activity
Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.
|
Behavioral: Physical activity
Promotoras provide appraisal support and negotiate behavior change goals with individual participants; provide instrumental support by organizing and leading physical activity classes within the churches and nearby church community; and advocate for church and neighborhood environmental changes that support increased moderate-to-vigorous physical activity.
|
|
Active Comparator: Cancer prevention
Latinas exposed to Fe en Acción intervention on general topics related to cancer prevention and control.
|
Behavioral: Cancer prevention
Promotoras provide workshop series on cancer prevention and control within the churches and nearby church community.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
Criteria
Inclusion Criteria:
- Between the ages of 18-65 years of age
- Latino
- Must be a member of a participating church for at least six months
- Live within 10-15 minutes driving distance from the church
- Able to travel to the church during the week
- Able to attend activities at the church during the week
- Attend church activities (worship or otherwise) at least 4 times a month
- Plan on living in same residence for the next 24 months
- Engage in less than 150 minutes of moderate-to-vigorous physical activity per week
Exclusion Criteria:
- Attendance at other churches participating in the study
- Must not have any conditions limiting ability to be physically active
- Pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776632
Contacts
| Contact: Kari H Burke, BA | 619-594-6307 | kburke@projects.sdsu.edu |
| Contact: Dayana Chanson, MPH | 619-594-7919 | dchanson@projects.sdsu.edu |
Locations
| United States, California | |
| San Diego State University Research Foundation | Recruiting |
| San Diego, California, United States, 92123 | |
| Principal Investigator: John P Elder, PhD, MPH | |
| Sub-Investigator: Guadalupe X Ayala, PhD | |
| Sub-Investigator: James F Sallis, PhD | |
| Sub-Investigator: Donald J Slymen, PhD | |
| Sub-Investigator: Sherry Ryan, PhD | |
Sponsors and Collaborators
San Diego State University
Investigators
| Principal Investigator: | Elva M Arredondo, PhD | San Diego State University |
More Information
No publications provided
| Responsible Party: | Elva Arredondo, Principal Investigator, San Diego State University |
| ClinicalTrials.gov Identifier: | NCT01776632 History of Changes |
| Other Study ID Numbers: | 5R01CA138894, 5R01CA138894-03 |
| Study First Received: | October 29, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Chronic Disease Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013