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Completed

NCT Number: NCT02046343

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Education

Behavioral

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.

Telephone counseling

Behavioral

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.

Newsletter

Other

Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.

Environmental Change

Other

Create a site atmosphere that promotes PA and increases the number of PA program offerings.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. Weight maintenance (Percent Body Fat)

    Time frame: 16 weeks

    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.

  3. 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.

  4. Weight maintenance (Waist Circumference)

    Time frame: 16 weeks

    Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

  5. 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.

  6. Weight maintenance (Waist Circumference)

    Time frame: 40 weeks

    Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

  7. 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.

  8. 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).

  9. Weight maintenance (Percent Body Fat)

    Time frame: 40 weeks

    Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2014
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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