Overview

This trial is active, not recruiting.

Condition physical activity
Treatments health education, telephone counseling, newsletter, environmental change
Sponsor The University of Texas Health Science Center at San Antonio
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date August 2012
End date April 2017
Trial size 712 participants
Trial identifier NCT02046343, HSC20110460H, R01HL111718

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
health 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.
telephone 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.
newsletter
Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.
environmental change
Create a site atmosphere that promotes PA and increases the number of PA program offerings.
(Placebo Comparator)
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.
health 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.

Primary Outcomes

Measure
Change from baseline Moderate-to-vigorous physical activity (MVPA)
time frame: 16 weeks

Secondary Outcomes

Measure
Change from baseline in Physical Fitness
time frame: 16 weeks
Weight maintenance (Percent Body Fat)
time frame: 16 weeks
Weight maintenance (Body Mass Index)
time frame: 16 weeks
Weight maintenance (Waist Circumference)
time frame: 16 weeks
Change from baseline Moderate-to-vigorous physical activity (MVPA)
time frame: 40 weeks
Weight maintenance (Waist Circumference)
time frame: 40 weeks
Weight maintenance (Body Mass Index)
time frame: 40 weeks
Change from baseline in Physical Fitness
time frame: 40 weeks
Weight maintenance (Percent Body Fat)
time frame: 40 weeks

Eligibility Criteria

Female participants from 18 years up to 64 years old.

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

Additional Information

Official title ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio.