Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Behavioral: Health education; Behavioral: Telephone Counseling; Other: Newsletter; Other: Environmental Change

• 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

Arm && Interventions

Group	Intervention	Description
Physical Activity	Health education	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.
Physical Activity	Telephone Counseling	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.
Physical Activity	Newsletter	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.
Physical Activity	Environmental Change	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.
Community Health and Safety	Health education	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.

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