Trial Outcomes & Findings for Promoting Physical Activity in Churchgoing Latinas (NCT NCT01776632)

Results Overview

Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

436 participants

Primary outcome timeframe

assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Results posted on

2021-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Physical Activity 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.	Cancer Screening 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 Study STARTED	217	219
Overall Study COMPLETED	190	190
Overall Study NOT COMPLETED	27	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Promoting Physical Activity in Churchgoing Latinas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Activity n=217 Participants 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.	Cancer Screening n=219 Participants 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 n=436 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 9.8 • n=5 Participants	44.4 years STANDARD_DEVIATION 9.4 • n=7 Participants	44.4 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	217 Participants n=5 Participants	219 Participants n=7 Participants	436 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	217 Participants n=5 Participants	219 Participants n=7 Participants	436 Participants n=5 Participants
Region of Enrollment United States	217 participants n=5 Participants	219 participants n=7 Participants	436 participants n=5 Participants
Accelerometer-based moderate-to-vigorous physical activity (MVPA)	98.8 minutes/week STANDARD_DEVIATION 61.5 • n=5 Participants	107.6 minutes/week STANDARD_DEVIATION 65.8 • n=7 Participants	103.2 minutes/week STANDARD_DEVIATION 63.8 • n=5 Participants
Self-report leisure-time MVPA	71.2 minutes/week STANDARD_DEVIATION 121.1 • n=5 Participants	64.0 minutes/week STANDARD_DEVIATION 104.1 • n=7 Participants	67.6 minutes/week STANDARD_DEVIATION 112.8 • n=5 Participants
BMI	30.8 kg/m2 STANDARD_DEVIATION 6.6 • n=5 Participants	29.9 kg/m2 STANDARD_DEVIATION 5.8 • n=7 Participants	30.3 kg/m2 STANDARD_DEVIATION 6.2 • n=5 Participants
Waist circumference	95.8 cm STANDARD_DEVIATION 15.0 • n=5 Participants	94.1 cm STANDARD_DEVIATION 14.3 • n=7 Participants	94.9 cm STANDARD_DEVIATION 14.7 • n=5 Participants

PRIMARY outcome

Timeframe: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Population: 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.

Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer

Outcome measures

Outcome measures
Measure	Physical Activity n=183 Participants 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.	Cancer Screening n=186 Participants 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.
Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)	144.4 minutes/week Standard Deviation 117.9	129.9 minutes/week Standard Deviation 125.6

PRIMARY outcome

Timeframe: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Population: 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.

Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity

Outcome measures

Outcome measures
Measure	Physical Activity n=187 Participants 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.	Cancer Screening n=188 Participants 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.
Self-report Leisure-time MVPA	138.2 minutes/week Standard Deviation 178.0	91.7 minutes/week Standard Deviation 134.4

SECONDARY outcome

Timeframe: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Population: 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.

Change from baseline in body mass index (BMI)

Outcome measures

Outcome measures
Measure	Physical Activity n=178 Participants 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.	Cancer Screening n=183 Participants 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.
Body Mass Index (BMI)	30.18 kg/m2 Standard Error 0.14	30.60 kg/m2 Standard Error 0.14

SECONDARY outcome

Timeframe: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Population: 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.

Change from baseline in waist circumference

Outcome measures

Outcome measures
Measure	Physical Activity n=178 Participants 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.	Cancer Screening n=183 Participants 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.
Waist Circumference	95.20 cm Standard Error 0.49	96.56 cm Standard Error 0.54

Adverse Events

Physical Activity

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Cancer Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Physical Activity n=217 participants at risk 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.	Cancer Screening n=219 participants at risk 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.
Injury, poisoning and procedural complications broken ankle	0.46% 1/217 • Number of events 1 • Baseline to 24 months (2 years)	0.00% 0/219 • Baseline to 24 months (2 years)

Additional Information

Elva Arredondo

San Diego State University

Phone: (619) 594-3481

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place