NCT01776632

Promoting Physical Activity in Churchgoing Latinas

Completed NA Results posted Last updated 29 September 2021

What this trial tests

NA trial testing Physical activity in Chronic Disease in 436 participants. Completed in 21 December 2015.

Timeline

11 May 2011

Primary endpoint
21 December 2015

21 December 2015

Quick facts

Lead sponsor	San Diego State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	436
Start date	11 May 2011
Primary completion	21 December 2015
Estimated completion	21 December 2015
Sites	1 location across United States

Drugs / interventions tested

• Physical activity
• Cancer screening

Conditions studied

• Chronic Disease — all drugs for Chronic Disease →

Sponsor

San Diego State University

Who can join

Adults 18 to 65, female only, with Chronic Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA) Primary · 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

Group	Value	95% CI
Physical Activity	144.4	± 117.9
Cancer Screening	129.9	± 125.6

Self-report Leisure-time MVPA Primary · 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

Group	Value	95% CI
Physical Activity	138.2	± 178.0
Cancer Screening	91.7	± 134.4

Body Mass Index (BMI) Secondary · assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Change from baseline in body mass index (BMI)

Group	Value	95% CI
Physical Activity	30.18	± 0.14
Cancer Screening	30.60	± 0.14

Waist Circumference Secondary · assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported

Change from baseline in waist circumference

Group	Value	95% CI
Physical Activity	95.20	± 0.49
Cancer Screening	96.56	± 0.54

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to 24 months (2 years). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Physical Activity

Serious: 0/217 (0%)

Deaths: 1/217

Cancer Screening

Serious: 0/219 (0%)

Deaths: 0/219

Other adverse events (1 terms — click to expand)

Reaction	System	Physical Activity	Cancer Screening
broken ankle	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT01776632 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Arredondo EM, Haughton J, Ayala GX, Slymen DJ, et al · · 2015 · cited 32× · PMID 26358535 · DOI 10.1016/j.cct.2015.09.008
2. Promoting cancer screening among churchgoing Latinas: Fe en Acción/faith in action.
   Elder JP, Haughton J, Perez LG, Martínez ME, et al · · 2017 · cited 25× · PMID 28380627 · DOI 10.1093/her/cyx033
3. Two-year outcomes of Faith in Action/Fe en Acción: a randomized controlled trial of physical activity promotion in Latinas.
   Arredondo EM, Haughton J, Ayala GX, Slymen D, et al · · 2022 · cited 9× · PMID 35907867 · DOI 10.1186/s12966-022-01329-6