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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 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elva Arredondo, San Diego State University

Tracking Information
First Submitted Date  ICMJE October 29, 2012
First Posted Date  ICMJE January 28, 2013
Results First Submitted Date  ICMJE February 4, 2019
Results First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE May 11, 2011
Actual Primary Completion Date December 21, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer and self-report [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
Change History Complete list of historical versions of study NCT01776632 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Change in Body Mass Index [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
  • Change in Waist Circumference [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
  • Change in Cardiovascular Fitness Level [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
    Submaximal Step Test
  • Change in Intrapersonal Mediators of PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
    The current study examines the following potential mediators of PA: self-efficacy for being physically active; benefits to PA; enjoyment of PA; and barriers to PA via self-report survey items.
  • Change in Interpersonal Mediators of PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
    The current study examines social support for PA via self-report survey items.
  • Change in Environmental Mediators of PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
    The current study examines the following environmental mediators of PA including perceived environment via self-report, as well as Geographic Information Systems (GIS) and direct observational measures of built environment changes targeted in the intervention.
  • Change in Potential Cultural Moderators on Latinas' PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
    The current study examines the moderating influence of factors that characterize the Latino culture (religious beliefs, acculturation and demographics).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Physical Activity in Churchgoing Latinas
Official Title  ICMJE Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chronic Disease
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Physical activity
    Latinas exposed to multi-level Faith in Action intervention promoting physical activity.
    Intervention: Behavioral: Physical activity
  • Active Comparator: Cancer screening
    Latinas exposed to Faith in Action intervention on cancer screening and prevention.
    Intervention: Behavioral: Cancer screening
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2015)
436
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2013)
464
Actual Study Completion Date  ICMJE December 21, 2015
Actual Primary Completion Date December 21, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776632
Other Study ID Numbers  ICMJE R01CA138894( U.S. NIH Grant/Contract )
R01CA138894-05S1 ( U.S. NIH Grant/Contract )
R01CA138894-05S2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elva Arredondo, San Diego State University
Study Sponsor  ICMJE San Diego State University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Elva M Arredondo, PhD San Diego State University
PRS Account San Diego State University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP