Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

Study Overview
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Brief Summary
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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.

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

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Health education
* Behavioral: Telephone Counseling
* Other: Newsletter
* Other: Environmental Change


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity<br>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<br>* 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.<br>Behavioral: Telephone Counseling<br>* 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.<br>Other: Newsletter<br>* Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.<br>Other: Environmental Change<br>* Create a site atmosphere that promotes PA and increases the number of PA program offerings.<br>|
| Placebo Comparator: Community Health and Safety<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 16 weeks | 
| Weight maintenance (Percent Body Fat) | Weight maintenance is defined as a change in % body fat less than ± 3% of baseline. | 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. | 16 weeks | 
| Weight maintenance (Waist Circumference) | 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) | 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) | Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline. | 40 weeks | 
| Weight maintenance (Body Mass Index) | 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 | The 2-minute step in place test will be used to assess cardiorespiratory fitness (steps/minute). | 40 weeks | 
| Weight maintenance (Percent Body Fat) | Weight maintenance is defined as a change in % body fat less than ± 3% of baseline. | 40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, prevention, health disparities, behavior, community based intervention