Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

August 28, 2018 updated by: Deborah Parra-Medina, The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
16 weeks
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.
16 weeks
Weight maintenance (Waist Circumference)
Time Frame: 16 weeks
Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.
16 weeks
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.
40 weeks
Weight maintenance (Waist Circumference)
Time Frame: 40 weeks
Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.
40 weeks
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.
40 weeks
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).
40 weeks
Weight maintenance (Percent Body Fat)
Time Frame: 40 weeks
Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

The University of Texas Health Science Center, Houston
National Heart, Lung, and Blood Institute (NHLBI)
University of Maryland
University of South Carolina
Texas A&M University
Texas Tech University Health Sciences Center, El Paso

Investigators

  • Principal Investigator: Deborah M Parra-Medina, PhD, UT Health San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC20110460H
  • R01HL111718 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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