Promoting Physical Activity in Churchgoing Latinas

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776632
• Other study ID #: R01CA138894
• Secondary ID: R01CA138894-05S1
• Status: Completed
• Phase: N/A
• Start date: May 11, 2011
• Est. completion date: December 21, 2015

Study information

• Verified date: September 2021
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: December 21, 2015
• Est. primary completion date: December 21, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• 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.
• Cancer screening
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.

Locations

Country	Name	City	State
United States	San Diego State University Research Foundation	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (12)

Arredondo EM, Elder JP, Haughton J, Slymen DJ, Sallis JF, Perez LG, Serrano N, Parra MT, Valdivia R, Ayala GX. Fe en Acción: Promoting Physical Activity Among Churchgoing Latinas. Am J Public Health. 2017 Jul;107(7):1109-1115. doi: 10.2105/AJPH.2017.30378 — View 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. — View 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. — View Citation

Elder JP, Haughton J, Perez LG, Martínez ME, De la Torre CL, Slymen DJ, Arredondo EM. Promoting cancer screening among churchgoing Latinas: Fe en Acción/faith in action. Health Educ Res. 2017 Apr 1;32(2):163-173. doi: 10.1093/her/cyx033. — View Citation

Haughton J, Ayala GX, Burke KH, Elder JP, Montañez 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. — View 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. eCollection 2016 Dec. — View 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. — View 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;:. — View 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. — View 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. — View 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. — View Citation

Tristão Parra M, Porfírio GJM, Arredondo EM, Atallah ÁN. 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)	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
Primary	Self-report Leisure-time MVPA	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	Body Mass Index (BMI)	Change from baseline in body mass index (BMI)	assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Secondary	Waist Circumference	Change from baseline in waist circumference	assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported