Chronic Disease
Conditions
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.
Interventions
BEHAVIORALPhysical 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.
BEHAVIORALCancer 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.
Sponsors
National Cancer Institute (NCI)
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Waist Circumference | assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported | Change from baseline in waist circumference |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity 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. | 217 |
| 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. | 219 |
| Total | 436 |
Baseline characteristics
| Characteristic | Physical Activity | Cancer Screening | Total |
|---|---|---|---|
| Accelerometer-based moderate-to-vigorous physical activity (MVPA) | 98.8 minutes/week STANDARD_DEVIATION 61.5 | 107.6 minutes/week STANDARD_DEVIATION 65.8 | 103.2 minutes/week STANDARD_DEVIATION 63.8 |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 9.8 | 44.4 years STANDARD_DEVIATION 9.4 | 44.4 years STANDARD_DEVIATION 9.6 |
| BMI | 30.8 kg/m2 STANDARD_DEVIATION 6.6 | 29.9 kg/m2 STANDARD_DEVIATION 5.8 | 30.3 kg/m2 STANDARD_DEVIATION 6.2 |
| Race/Ethnicity, Customized Hispanic/Latino | 217 Participants | 219 Participants | 436 Participants |
| Region of Enrollment United States | 217 participants | 219 participants | 436 participants |
| Self-report leisure-time MVPA | 71.2 minutes/week STANDARD_DEVIATION 121.1 | 64.0 minutes/week STANDARD_DEVIATION 104.1 | 67.6 minutes/week STANDARD_DEVIATION 112.8 |
| Sex: Female, Male Female | 217 Participants | 219 Participants | 436 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Waist circumference | 95.8 cm STANDARD_DEVIATION 15 | 94.1 cm STANDARD_DEVIATION 14.3 | 94.9 cm STANDARD_DEVIATION 14.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 217 | 0 / 219 |
| other Total, other adverse events | 1 / 217 | 0 / 219 |
| serious Total, serious adverse events | 0 / 217 | 0 / 219 |
Outcome results
Primary
Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA) | 144.4 minutes/week | Standard Deviation 117.9 |
| Cancer Screening | Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA) | 129.9 minutes/week | Standard Deviation 125.6 |
p-value: 0.03generalized linear mixed effects
Primary
Self-report Leisure-time MVPA
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Self-report Leisure-time MVPA | 138.2 minutes/week | Standard Deviation 178 |
| Cancer Screening | Self-report Leisure-time MVPA | 91.7 minutes/week | Standard Deviation 134.4 |
p-value: 0.003generalized linear mixed effects
Secondary
Body Mass Index (BMI)
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Body Mass Index (BMI) | 30.18 kg/m2 | Standard Error 0.14 |
| Cancer Screening | Body Mass Index (BMI) | 30.60 kg/m2 | Standard Error 0.14 |
p-value: 0.04mixed effects models
Secondary
Waist Circumference
Change from baseline in waist circumference
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity | Waist Circumference | 95.20 cm | Standard Error 0.49 |
| Cancer Screening | Waist Circumference | 96.56 cm | Standard Error 0.54 |
p-value: 0.09mixed effects models