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Promoting Physical Activity in Churchgoing Latinas

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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

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 21, 2015
Actual Study Completion Date : December 21, 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported ]
    Change from baseline in waist circumference



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776632


Locations
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United States, California
San Diego State University Research Foundation
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elva M Arredondo, PhD San Diego State University

Publications of Results:
Other Publications:

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Responsible Party: Elva Arredondo, Principal Investigator, 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 Posted: January 28, 2013    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes