Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by The University of Texas Health Science Center at San Antonio
Sponsor:
Collaborators:
University of South Carolina, Columbia SC
University of Texas Health Science Center, Houston TX
Information provided by (Responsible Party):
Deborah Parra-Medina, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT02046343
First received: January 22, 2014
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The purpose of this study it to determine if a promotora-led intervention that takes a comprehensive, multi-level, community-based approach to promoting physical activity (PA) is effective among a particularly underserved segment of Latinas. We hypothesize that Latinas in the promotora-led PA Intervention will significantly increase minutes per week of moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control group.


Condition Intervention
Physical Activity
Behavioral: Health education
Behavioral: Telephone Counseling
Other: Newsletter
Other: Environmental Change

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: ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Change from baseline Moderate-to-vigorous physical activity (MVPA) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Minutes per week of MVPA is assessed a baseline and immediate post-intervention (16 weeks) using accelerometry. The primary outcome is the amount of change between baseline and immediate post-intervention.


Secondary Outcome Measures:
  • Change from baseline in Physical Fitness [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The "2-minute step in place" test will be used to assess the amount of change in cardiorespiratory fitness (steps/minute) between baseline and immediate post-intervention (16 weeks).

  • Weight maintenance (Percent Body Fat) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.

  • Weight maintenance (Body Mass Index) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.

  • Weight maintenance (Waist Circumference) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

  • Change from baseline Moderate-to-vigorous physical activity (MVPA) [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Minutes per week of MVPA is assessed a baseline and 24 weeks post-intervention (40 weeks) using accelerometry. The amount of change between baseline and 24 weeks post-intervention will be used to determine if the behavior was maintained.

  • Weight maintenance (Waist Circumference) [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

  • Weight maintenance (Body Mass Index) [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.

  • Change from baseline in Physical Fitness [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    The 2-minute step in place test will be used to assess cardiorespiratory fitness (steps/minute).

  • Weight maintenance (Percent Body Fat) [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.


Estimated Enrollment: 704
Study Start Date: August 2012
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity
Weekly promotora-led group sessions on physical activity (16 weeks) and followed by monthly telephone counseling and newsletters during the 24 week maintenance period. Promotoras will also implement environmental change strategies to increase the number of PA program offerings available to study participants.
Behavioral: Health education
Group health education sessions delivered by a promotora approximately 90 minutes in length. In the PA arm, health education incorporates at least 30 minutes group exercise.
Behavioral: Telephone Counseling
Brief (10 minute) telephone counseling calls delivered by promotoras using motivational interviewing techniques. The counseling calls will emphasize behavior change strategies, including self-monitoring, goal setting, reinforcement, problem solving, stimulus control, and enlisting social support.
Other: Newsletter
Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.
Other: Environmental Change
Create a site atmosphere that promotes PA and increases the number of PA program offerings.
Placebo Comparator: Community Health and Safety
Weekly promotora-led group sessions on home safety/first aid (16 weeks) followed by and monthly generic health education materials and informational telephone calls during the 24 week maintenance period.
Behavioral: Health education
Group health education sessions delivered by a promotora approximately 90 minutes in length. In the PA arm, health education incorporates at least 30 minutes group exercise.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women ages 18-64 years
  • self-identify as Hispanic
  • have a personal telephone
  • reside within and intend to stay in the specified areas over the entire study period
  • understand Spanish
  • do not currently meet national PA recommendations

Exclusion Criteria:

  • currently pregnant or plan to become pregnant
  • insulin dependent diabetic
  • uncontrolled hypertension
  • undergoing therapy for life-threatening illnesses (chemotherapy or radiation therapy)
  • positive (risk) responses on the PA Readiness Questionnaire (PAR-Q) and subsequent physician disapproval
  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: NCT02046343

Contacts
Contact: Deborah M Parra-Medina, PhD 210-562-6521 parramedina@uthscsa.edu
Contact: Laura Esparza, MS 210-562-6514 esparzal@uthscsa.edu

Locations
United States, Texas
University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Laura Esparza, MS    210-562-6514    EsparzaL@uthscsa.edu   
Contact: Sonio D Garcia, MS    956-365-8642    GarciaSD@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
University of South Carolina, Columbia SC
University of Texas Health Science Center, Houston TX
  More Information

Additional Information:
No publications provided

Responsible Party: Deborah Parra-Medina, Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02046343     History of Changes
Other Study ID Numbers: R01HL111718
Study First Received: January 22, 2014
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
physical activity
prevention
health disparities
behavior
community based intervention

ClinicalTrials.gov processed this record on July 26, 2014