Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Promoting Physical Activity in Churchgoing Latinas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01776632
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elva Arredondo, San Diego State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Chronic Disease
Interventions Behavioral: Physical activity
Behavioral: Cancer screening
Enrollment 436
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Physical Activity Cancer Screening
Hide 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
Arm/Group Title Physical Activity Cancer Screening Total
Hide 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 Number of Baseline Participants 217 219 436
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 217 participants 219 participants 436 participants
44.5  (9.8) 44.4  (9.4) 44.4  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 219 participants 436 participants
Female
217
 100.0%
219
 100.0%
436
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic/Latino Number Analyzed 217 participants 219 participants 436 participants
217
 100.0%
219
 100.0%
436
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 217 participants 219 participants 436 participants
217 219 436
Accelerometer-based moderate-to-vigorous physical activity (MVPA)  
Mean (Standard Deviation)
Unit of measure:  Minutes/week
Number Analyzed 217 participants 219 participants 436 participants
98.8  (61.5) 107.6  (65.8) 103.2  (63.8)
Self-report leisure-time MVPA  
Mean (Standard Deviation)
Unit of measure:  Minutes/week
Number Analyzed 217 participants 219 participants 436 participants
71.2  (121.1) 64.0  (104.1) 67.6  (112.8)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 217 participants 219 participants 436 participants
30.8  (6.6) 29.9  (5.8) 30.3  (6.2)
Waist circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 217 participants 219 participants 436 participants
95.8  (15.0) 94.1  (14.3) 94.9  (14.7)
1.Primary Outcome
Title Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 183 186
Mean (Standard Deviation)
Unit of Measure: minutes/week
144.4  (117.9) 129.9  (125.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physical Activity, Cancer Screening
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method generalized linear mixed effects
Comments [Not Specified]
Method of Estimation Estimation Parameter difference of adjusted means
Estimated Value 0.15
Estimation Comments [Not Specified]
2.Primary Outcome
Title Self-report Leisure-time MVPA
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 187 188
Mean (Standard Deviation)
Unit of Measure: minutes/week
138.2  (178.0) 91.7  (134.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physical Activity, Cancer Screening
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments [Not Specified]
Method generalized linear mixed effects
Comments [Not Specified]
Method of Estimation Estimation Parameter difference of adjusted means
Estimated Value 0.39
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Body Mass Index (BMI)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 178 183
Mean (Standard Error)
Unit of Measure: kg/m2
30.18  (0.14) 30.60  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physical Activity, Cancer Screening
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments [Not Specified]
Method mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter difference of adjusted means
Estimated Value -0.43
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Waist Circumference
Hide Description Change from baseline in waist circumference
Time Frame assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 178 183
Mean (Standard Error)
Unit of Measure: cm
95.20  (0.49) 96.56  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physical Activity, Cancer Screening
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .09
Comments [Not Specified]
Method mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter difference of adjusted means
Estimated Value -1.27
Estimation Comments [Not Specified]
Time Frame Baseline to 24 months (2 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Physical Activity Cancer Screening
Hide 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 (%) Affected / at Risk (%)
Total   1/217 (0.46%)      0/219 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Physical Activity Cancer Screening
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/217 (0.00%)      0/219 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Physical Activity Cancer Screening
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/217 (0.46%)      0/219 (0.00%)    
Injury, poisoning and procedural complications     
broken ankle  [1]  1/217 (0.46%)  1 0/219 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Study participant fell and broke ankle during walking group
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.
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.
Results Point of Contact
Name/Title: Elva Arredondo
Organization: San Diego State University
Phone: (619) 594-3481
Other Publications:
Responsible Party: Elva Arredondo, San Diego State University
ClinicalTrials.gov Identifier: NCT01776632     History of Changes
Other Study ID Numbers: R01CA138894 ( U.S. NIH Grant/Contract )
R01CA138894-05S1 ( U.S. NIH Grant/Contract )
R01CA138894-05S2 ( U.S. NIH Grant/Contract )
First Submitted: October 29, 2012
First Posted: January 28, 2013
Results First Submitted: February 4, 2019
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019