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Promoting Physical Activity in Churchgoing Latinas

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity
Cancer screening
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • San Diego State University Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical activity

Cancer screening

Arm Description

Latinas exposed to multi-level Faith in Action intervention promoting physical activity.

Latinas exposed to Faith in Action intervention on cancer screening and prevention.

Outcomes

Primary Outcome Measures

Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer
Self-report Leisure-time MVPA
Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity

Secondary Outcome Measures

Body Mass Index (BMI)
Change from baseline in body mass index (BMI)
Waist Circumference
Change from baseline in waist circumference

Full Information

First Posted
October 29, 2012
Last Updated
September 27, 2021
Sponsor
San Diego State University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01776632
Brief Title
Promoting Physical Activity in Churchgoing Latinas
Official Title
Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2011 (Actual)
Primary Completion Date
December 21, 2015 (Actual)
Study Completion Date
December 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.., 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity
Arm Type
Experimental
Arm Description
Latinas exposed to multi-level Faith in Action intervention promoting physical activity.
Arm Title
Cancer screening
Arm Type
Active Comparator
Arm Description
Latinas exposed to Faith in Action intervention on cancer screening and prevention.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Faith in Action, Fe en Acción
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cancer screening
Intervention Description
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 Outcome Measure Information:
Title
Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
Description
Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer
Time Frame
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Title
Self-report Leisure-time MVPA
Description
Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity
Time Frame
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Change from baseline in body mass index (BMI)
Time Frame
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Title
Waist Circumference
Description
Change from baseline in waist circumference
Time Frame
assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elva M Arredondo, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26358535
Citation
Arredondo EM, Haughton J, Ayala GX, Slymen DJ, Sallis JF, Burke K, Holub C, Chanson D, Perez LG, Valdivia R, Ryan S, Elder J. Fe en Accion/Faith in Action: Design and implementation of a church-based randomized trial to promote physical activity and cancer screening among churchgoing Latinas. Contemp Clin Trials. 2015 Nov;45(Pt B):404-415. doi: 10.1016/j.cct.2015.09.008. Epub 2015 Sep 8.
Results Reference
background
PubMed Identifier
26280587
Citation
Haughton J, Ayala GX, Burke KH, Elder JP, Montanez J, Arredondo EM. Community Health Workers Promoting Physical Activity: Targeting Multiple Levels of the Social Ecological Model. J Ambul Care Manage. 2015 Oct-Dec;38(4):309-20. doi: 10.1097/JAC.0000000000000108.
Results Reference
background
PubMed Identifier
27536927
Citation
Beard M, Chuang E, Haughton J, Arredondo EM. Determinants of Implementation Effectiveness in a Physical Activity Program for Church-Going Latinas. Fam Community Health. 2016 Oct-Dec;39(4):225-33. doi: 10.1097/FCH.0000000000000122.
Results Reference
background
PubMed Identifier
27412175
Citation
Perez LG, Slymen DJ, Sallis JF, Ayala GX, Elder JP, Arredondo EM. Interactions between individual and perceived environmental factors on Latinas' physical activity. J Public Health (Oxf). 2017 Jun 1;39(2):e10-e18. doi: 10.1093/pubmed/fdw061.
Results Reference
background
PubMed Identifier
27679665
Citation
Perez LG, Chavez A, Marquez DX, Soto SC, Haughton J, Arredondo EM. Associations of Acculturation With Self-Report and Objective Physical Activity and Sedentary Behaviors Among Latinas. Health Educ Behav. 2017 Jun;44(3):431-438. doi: 10.1177/1090198116669802. Epub 2016 Sep 27.
Results Reference
background
PubMed Identifier
27818913
Citation
Perez LG, Carlson J, Slymen DJ, Patrick K, Kerr J, Godbole S, Elder JP, Ayala GX, Arredondo EM. Does the social environment moderate associations of the built environment with Latinas' objectively-measured neighborhood outdoor physical activity? Prev Med Rep. 2016 Oct 19;4:551-557. doi: 10.1016/j.pmedr.2016.10.006. eCollection 2016 Dec.
Results Reference
background
PubMed Identifier
29214856
Citation
Tristao Parra M, Porfirio GJM, Arredondo EM, Atallah AN. Physical Activity Interventions in Faith-Based Organizations: A Systematic Review. Am J Health Promot. 2018 Mar;32(3):677-690. doi: 10.1177/0890117116688107. Epub 2017 Jan 13.
Results Reference
background
PubMed Identifier
28380627
Citation
Elder JP, Haughton J, Perez LG, Martinez ME, De la Torre CL, Slymen DJ, Arredondo EM. Promoting cancer screening among churchgoing Latinas: Fe en Accion/faith in action. Health Educ Res. 2017 Apr 1;32(2):163-173. doi: 10.1093/her/cyx033.
Results Reference
background
PubMed Identifier
28359166
Citation
Soto SH, Arredondo EM, Haughton J, Shakya H. Leisure-Time Physical Activity and Characteristics of Social Network Support for Exercise Among Latinas. Am J Health Promot. 2018 Feb;32(2):432-439. doi: 10.1177/0890117117699927. Epub 2017 Mar 31.
Results Reference
background
PubMed Identifier
28752364
Citation
Perez LG, Elder JP, Haughton J, Martinez ME, Arredondo EM. Socio-demographic Moderators of Associations Between Psychological Factors and Latinas' Breast Cancer Screening Behaviors. J Immigr Minor Health. 2018 Aug;20(4):823-830. doi: 10.1007/s10903-017-0633-1. Erratum In: J Immigr Minor Health. 2017 Aug 9;:
Results Reference
background
PubMed Identifier
29166779
Citation
Perez LG, Kerr J, Sallis JF, Slymen D, McKenzie TL, Elder JP, Arredondo EM. Perceived Neighborhood Environmental Factors That Maximize the Effectiveness of a Multilevel Intervention Promoting Physical Activity Among Latinas. Am J Health Promot. 2018 Feb;32(2):334-343. doi: 10.1177/0890117117742999. Epub 2017 Nov 22.
Results Reference
background
PubMed Identifier
28520484
Citation
Arredondo EM, Elder JP, Haughton J, Slymen DJ, Sallis JF, Perez LG, Serrano N, Parra MT, Valdivia R, Ayala GX. Fe en Accion: Promoting Physical Activity Among Churchgoing Latinas. Am J Public Health. 2017 Jul;107(7):1109-1115. doi: 10.2105/AJPH.2017.303785. Epub 2017 May 18.
Results Reference
result
PubMed Identifier
35907867
Citation
Arredondo EM, Haughton J, Ayala GX, Slymen D, Sallis JF, Perez LG, Serrano N, Ryan S, Valdivia R, Lopez NV, Elder JP. Two-year outcomes of Faith in Action/Fe en Accion: a randomized controlled trial of physical activity promotion in Latinas. Int J Behav Nutr Phys Act. 2022 Jul 30;19(1):97. doi: 10.1186/s12966-022-01329-6.
Results Reference
derived

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Promoting Physical Activity in Churchgoing Latinas

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