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Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02046343
Enrollment
712
Registered
2014-01-27
Start date
2012-08-31
Completion date
2016-12-31
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

physical activity, prevention, health disparities, behavior, community based intervention

Brief summary

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.

Interventions

BEHAVIORALHealth 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.

BEHAVIORALTelephone 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.

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

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Moderate-to-vigorous physical activity (MVPA)16 weeksMinutes 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

MeasureTime frameDescription
Change from baseline in Physical Fitness16 weeksThe 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)16 weeksWeight maintenance is defined as a change in % body fat less than ± 3% of baseline.
Weight maintenance (Body Mass Index)16 weeksWeight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.
Weight maintenance (Waist Circumference)16 weeksWeight maintenance is defined as a change in waist circumference less than ± 3% of baseline.
Change from baseline Moderate-to-vigorous physical activity (MVPA)40 weeksMinutes 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026