Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

Not Applicable

Completed

• Conditions: Physical Activity

• Registration Number: NCT02046343
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 712

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline Moderate-to-vigorous physical activity (MVPA)	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 Outcome Measures

Name	Time	Method
Weight maintenance (Percent Body Fat)	40 weeks	Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.
Change from baseline in Physical Fitness	40 weeks	The 2-minute step in place test will be used to assess cardiorespiratory fitness (steps/minute).
Weight maintenance (Body Mass Index)	40 weeks	Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.
Change from baseline Moderate-to-vigorous physical activity (MVPA)	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.
Weight maintenance (Waist Circumference)	40 weeks	Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.

Trial Locations

Locations (1)

University of Texas Health Science Center San Antonio; 🇺🇸 San Antonio, Texas, United States