Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

N/ACompletedNCT02046343

The University of Texas Health Science Center at San Antonio712 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

712

Conditions

Physical Activity

Interventions

Health educationBEHAVIORAL

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 CounselingBEHAVIORAL

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.

NewsletterOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Change from baseline Moderate-to-vigorous physical activity (MVPA)

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.

Time frame: 16 weeks

Secondary Outcomes

Change from baseline in Physical Fitness

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).

Time frame: 16 weeks

Weight maintenance (Percent Body Fat)

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

Time frame: 16 weeks

Weight maintenance (Body Mass Index)

Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.

Time frame: 16 weeks

Weight maintenance (Waist Circumference)

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

Time frame: 16 weeks

Change from baseline Moderate-to-vigorous physical activity (MVPA)

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.

Time frame: 40 weeks

Weight maintenance (Waist Circumference)

Data from ClinicalTrials.gov

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