An interventional study of Health education and Telephone Counseling in Physical Activity, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Prevention
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.
The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
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Exclusion Criteria:
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 · Behavioral: Telephone Counseling · Other: Newsletter · Other: Environmental Change
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
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.
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.
Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.
Create a site atmosphere that promotes PA and increases the number of PA program offerings.
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
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)
Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.
Time frame: 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.
Time frame: 40 weeks
Change from baseline in Physical Fitness
The 2-minute step in place test will be used to assess cardiorespiratory fitness (steps/minute).
Time frame: 40 weeks
Weight maintenance (Percent Body Fat)
Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.
Time frame: 40 weeks
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio