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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
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.., 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 or disease Intervention/treatment
Chronic Disease Behavioral: Physical activity Behavioral: Cancer prevention

Study Design

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
Primary Completion Date : December 21, 2015
Study Completion Date : December 21, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
  2. Change in Waist Circumference [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
  3. Change in Cardiovascular Fitness Level [ Time Frame: Baseline, 12 and 24 months following implementation of intervention activities ]
    Submaximal Step Test

  4. 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.

  5. 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.

  6. 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.

  7. 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).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (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
Contacts and Locations

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
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
Principal Investigator: Elva M Arredondo, PhD San Diego State University
More Information

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
Last Update Posted: May 10, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes