Overview

This trial is active, not recruiting.

Condition chronic disease
Treatments physical activity, cancer prevention
Sponsor San Diego State University
Collaborator National Cancer Institute (NCI)
Start date March 2010
End date December 2015
Trial size 436 participants
Trial identifier NCT01776632, 5R01CA138894, 5R01CA138894-03

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.
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)
Latinas exposed to Fe en Acción intervention on general topics related to cancer prevention and control.
cancer prevention
Promotoras provide workshop series on cancer prevention and control within the churches and nearby church community.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Change in Body Mass Index
time frame: Baseline, 12 and 24 months following implementation of intervention activities
Change in Waist Circumference
time frame: Baseline, 12 and 24 months following implementation of intervention activities
Change in Cardiovascular Fitness Level
time frame: Baseline, 12 and 24 months following implementation of intervention activities
Change in Intrapersonal Mediators of PA
time frame: Baseline, 12 and 24 months following implementation of intervention activities
Change in Interpersonal Mediators of PA
time frame: Baseline, 12 and 24 months following implementation of intervention activities
Change in Environmental Mediators of PA
time frame: Baseline, 12 and 24 months following implementation of intervention activities
Change in Potential Cultural Moderators on Latinas' PA
time frame: Baseline, 12 and 24 months following implementation of intervention activities

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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

Additional Information

Official title Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)
Principal investigator Elva M Arredondo, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by San Diego State University.