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Completed

NCT Number: NCT01776632

Promoting Physical Activity in Churchgoing Latinas

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.., interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer screening and prevention.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University Research Foundation

San Diego, California, 92123, United States

About this study

This two-group randomized controlled trial combines innovative and traditional methods for promoting moderate-to-vigorous physical activity (MVPA) and cancer screening (breast, cervical, colorectal, and skin) among Latinas, and is tested simultaneously in a two-group design. Both interventions lasted two years. The study's primary outcome was min/week of accelerometer-assessed MVPA at baseline (M1) and 12 months (M2) and 24 months (M3) following the start of the intervention.We selected cancer screening as a comparison condition given the relevance of this topic to our target community (i.e., low cervical and colorectal cancer screening rates and follow-up). It was hypothesized that over time, participants in the physical activity condition would engage in significantly higher levels of MVPA, compared to participants in the cancer screening condition. We also expected greater changes in individual-, interpersonal-, and environmental-level correlates of physical activity among participants in the physical activity condition compared to those in the cancer screening condition. Conversely, we expected that participants in the cancer screening condition would engage in higher screening rates compared to those in the physical activity intervention.We anticipated greater changes in individual, interpersonal, and environmental correlates of cancer screening in this condition compared to the physical activity condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors.

Other names: Faith in Action, Fe en Acción

Cancer screening

Behavioral

Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals.

Primary outcomes

  1. Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)

    Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

    Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer

  2. Self-report Leisure-time MVPA

    Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

    Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

    Change from baseline in body mass index (BMI)

  2. Waist Circumference

    Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

    Change from baseline in waist circumference

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2013
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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