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Promoting Physical Activity in Churchgoing Latinas

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by San Diego State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elva Arredondo, San Diego State University
ClinicalTrials.gov Identifier:
NCT01776632
First received: October 29, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.., intra/interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer prevention and control via screening.

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 Intervention
Chronic Disease
Behavioral: Physical activity
Behavioral: Cancer prevention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Body Mass Index [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]
  • Change in Waist Circumference [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]
  • Change in Cardiovascular Fitness Level [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]
    Submaximal Step Test

  • Change in Intrapersonal Mediators of PA [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The current study examines the moderating influence of factors that characterize the Latino culture (religious beliefs, acculturation and demographics).


Estimated Enrollment: 464
Study Start Date: March 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity
Latinas exposed to multi-level Fe en Acción intervention promoting physical activity.
Behavioral: Physical activity
Promotoras provide appraisal support and negotiate behavior change goals with individual participants; provide instrumental support by organizing and leading physical activity classes within the churches and nearby church community; and advocate for church and neighborhood environmental changes that support increased moderate-to-vigorous physical activity.
Active Comparator: Cancer prevention
Latinas exposed to Fe en Acción intervention on general topics related to cancer prevention and control.
Behavioral: Cancer prevention
Promotoras provide workshop series on cancer prevention and control within the churches and nearby church community.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776632

Contacts
Contact: Kari H Burke, BA 619-594-6307 kburke@projects.sdsu.edu
Contact: Dayana Chanson, MPH 619-594-7919 dchanson@projects.sdsu.edu

Locations
United States, California
San Diego State University Research Foundation Recruiting
San Diego, California, United States, 92123
Principal Investigator: John P Elder, PhD, MPH         
Sub-Investigator: Guadalupe X Ayala, PhD         
Sub-Investigator: James F Sallis, PhD         
Sub-Investigator: Donald J Slymen, PhD         
Sub-Investigator: Sherry Ryan, PhD         
Sponsors and Collaborators
San Diego State University
Investigators
Principal Investigator: Elva M Arredondo, PhD San Diego State University
  More Information

No publications provided

Responsible Party: Elva Arredondo, Principal Investigator, San Diego State University
ClinicalTrials.gov Identifier: NCT01776632     History of Changes
Other Study ID Numbers: 5R01CA138894, 5R01CA138894-03
Study First Received: October 29, 2012
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014