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Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02046343
First Posted: January 27, 2014
Last Update Posted: July 28, 2017
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.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of South Carolina
The University of Texas Health Science Center, Houston
Texas A&M University
Information provided by (Responsible Party):
Deborah Parra-Medina, The University of Texas Health Science Center at San Antonio
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Deborah Parra-Medina, 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 ]
    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 ]
    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 ]
    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.

  • Weight maintenance (Body Mass Index) [ Time Frame: 16 weeks ]
    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 ]
    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 ]
    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 ]
    Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

  • Weight maintenance (Body Mass Index) [ Time Frame: 40 weeks ]
    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 ]
    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 ]
    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.


Enrollment: 712
Study Start Date: August 2012
Estimated Study Completion Date: May 31, 2018
Primary Completion Date: December 31, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes 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
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): NCT02046343


Locations
United States, Texas
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Heart, Lung, and Blood Institute (NHLBI)
University of South Carolina
The University of Texas Health Science Center, Houston
Texas A&M University
  More Information

Additional Information:
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 ( U.S. NIH Grant/Contract )
HSC20110460H ( Other Identifier: UT Health Science Center Institutional Review Board )
First Submitted: January 22, 2014
First Posted: January 27, 2014
Last Update Posted: July 28, 2017
Last Verified: July 2017

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