Promoting Physical Activity in Churchgoing Latinas

• Sponsor: San Diego State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01776632
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 436
• Location: 1
• Arms: 2
• Actual Duration (Months): 55.4
• Patients Per Site Per Month: 7.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease	Behavioral: Physical activity; Behavioral: Cancer screening	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 436 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)
• Actual Study Start Date: May 11, 2011
• Actual Primary Completion Date: Dec 21, 2015
• Actual Study Completion Date: Dec 21, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity Latinas exposed to multi-level Faith in Action intervention promoting physical activity.	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.; Other Names: Faith in Action Fe en Acción
Active Comparator: Cancer screening Latinas exposed to Faith in Action intervention on cancer screening and prevention.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

1. Body Mass Index (BMI) [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 [assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported]

   Change from baseline in waist circumference

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego State University Research Foundation	San Diego	California	United States	92123

Sponsors and Collaborators

• San Diego State University
• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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;:.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Elva Arredondo, Principal Investigator, San Diego State University
• ClinicalTrials.gov Identifier: NCT01776632
• Other Study ID Numbers: R01CA138894; R01CA138894-05S1; R01CA138894-05S2
• First Posted: Jan 28, 2013
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Chronic Disease

Study Results

Participant Flow

Arm/Group Title	Physical Activity	Cancer Screening
Arm/Group Description	Latinas exposed to multi-level Faith in Action intervention promoting physical activity. 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.	Latinas exposed to Faith in Action intervention on cancer screening and prevention. 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. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.
Period Title: Overall Study
STARTED	217	219
COMPLETED	190	190
NOT COMPLETED	27	29

Baseline Characteristics

Arm/Group Title	Physical Activity	Cancer Screening	Total
Arm/Group Description	Latinas exposed to multi-level Fe en Acción intervention promoting physical activity. 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.	Latinas exposed to Faith in Action intervention on cancer screening and prevention. 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. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.	Total of all reporting groups
Overall Participants	217	219	436
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.5 (9.8)	44.4 (9.4)	44.4 (9.6)
Sex: Female, Male (Count of Participants)
Female	217 100%	219 100%	436 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latino	217 100%	219 100%	436 100%
Region of Enrollment (participants) [Number]
United States	217 100%	219 100%	436 100%
Accelerometer-based moderate-to-vigorous physical activity (MVPA) (minutes/week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes/week]	98.8 (61.5)	107.6 (65.8)	103.2 (63.8)
Self-report leisure-time MVPA (minutes/week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes/week]	71.2 (121.1)	64.0 (104.1)	67.6 (112.8)
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	30.8 (6.6)	29.9 (5.8)	30.3 (6.2)
Waist circumference (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	95.8 (15.0)	94.1 (14.3)	94.9 (14.7)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

A total of 369 participants (183 physical activity condition, 186 cancer screening condition) had valid accelerometer data at 12-month follow-up measures. Those without valid data (unmet wear time, lost device, etc) were not included in the analysis.

Arm/Group Title	Physical Activity	Cancer Screening
Arm/Group Description	Latinas exposed to multi-level Fe en Acción intervention promoting physical activity. 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.	Latinas exposed to Faith in Action intervention on cancer screening and prevention. 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. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.
Measure Participants	183	186
Mean (Standard Deviation) [minutes/week]	144.4 (117.9)	129.9 (125.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Activity, Cancer Screening
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.03
	Comments
	Method	generalized linear mixed effects
	Comments
Method of Estimation	Estimation Parameter	difference of adjusted means
	Estimated Value	0.15
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

A total of 375 participants (187 physical activity condition, 188 cancer screening condition) had valid self-report leisure-time data at 12-month follow-up measures. Those without valid data (incomplete data, etc) were not included in the analysis.

Arm/Group Title	Physical Activity	Cancer Screening
Arm/Group Description	Latinas exposed to multi-level Fe en Acción intervention promoting physical activity. 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.	Latinas exposed to Faith in Action intervention on cancer screening and prevention. 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. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.
Measure Participants	187	188
Mean (Standard Deviation) [minutes/week]	138.2 (178.0)	91.7 (134.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Activity, Cancer Screening
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.003
	Comments
	Method	generalized linear mixed effects
	Comments
Method of Estimation	Estimation Parameter	difference of adjusted means
	Estimated Value	0.39
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

A total of 361 participants (178 physical activity condition, 183 cancer screening condition) had valid BMI data at 12-month follow-up measures. Those without valid data (incomplete anthrometric measures, etc) were not included in the analysis.

Arm/Group Title	Physical Activity	Cancer Screening
Arm/Group Description	Latinas exposed to multi-level Fe en Acción intervention promoting physical activity. 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.	Latinas exposed to Faith in Action intervention on cancer screening and prevention. 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. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.
Measure Participants	178	183
Mean (Standard Error) [kg/m2]	30.18 (0.14)	30.60 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Activity, Cancer Screening
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.04
	Comments
	Method	mixed effects models
	Comments
Method of Estimation	Estimation Parameter	difference of adjusted means
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

A total of 361 participants (178 physical activity condition, 183 cancer screening condition) had valid waist circumference data at 12-month follow-up measures. Those without valid data (incomplete anthropometrics, etc) were not included in the analysis.

Arm/Group Title	Physical Activity	Cancer Screening
Arm/Group Description	Latinas exposed to multi-level Fe en Acción intervention promoting physical activity. 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.	Latinas exposed to Faith in Action intervention on cancer screening and prevention. 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. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.
Measure Participants	178	183
Mean (Standard Error) [cm]	95.20 (0.49)	96.56 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Physical Activity, Cancer Screening
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.09
	Comments
	Method	mixed effects models
	Comments
Method of Estimation	Estimation Parameter	difference of adjusted means
	Estimated Value	-1.27
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline to 24 months (2 years)
Arm/Group Title	Physical Activity		Cancer Screening
Arm/Group Description	Latinas exposed to multi-level Faith in Action intervention promoting physical activity. 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.		Latinas exposed to Faith in Action intervention on cancer screening and prevention. 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. Workshops were hosted at the church and promoted through bulletins and service announcements. Faith components were included throughout the intervention, including prayers before and after each workshop and phone call.
All Cause Mortality
	Physical Activity		Cancer Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/217 (0.5%)		0/219 (0%)
Serious Adverse Events
	Physical Activity		Cancer Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/217 (0%)		0/219 (0%)
Other (Not Including Serious) Adverse Events
	Physical Activity		Cancer Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/217 (0.5%)		0/219 (0%)
Injury, poisoning and procedural complications
broken ankle	1/217 (0.5%)	1	0/219 (0%)	0

Limitations/Caveats

The current study was implemented with Latina women attending Catholic churches, the findings may not generalize to men, members of other ethnic groups, or Latino groups of other denominations.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.