Promoting Physical Activity in Churchgoing Latinas

September 27, 2021 updated by: Elva Arredondo, San Diego State University

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92123
        • San Diego State University Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical activity
Latinas exposed to multi-level Faith in Action intervention promoting physical activity.
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
Active Comparator: Cancer screening
Latinas exposed to Faith in Action intervention on cancer screening and prevention.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
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
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elva M Arredondo, PhD, San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2011

Primary Completion (Actual)

December 21, 2015

Study Completion (Actual)

December 21, 2015

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • R01CA138894 (U.S. NIH Grant/Contract)
  • R01CA138894-05S1 (U.S. NIH Grant/Contract)
  • R01CA138894-05S2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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