- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02046343
Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
August 28, 2018 updated by: Deborah Parra-Medina, The University of Texas Health Science Center at San Antonio
ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
712
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center San Antonio
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical Activity
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.
|
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.
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Placebo Comparator: Community Health and Safety
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Moderate-to-vigorous physical activity (MVPA)
Time Frame: 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.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Physical Fitness
Time Frame: 16 weeks
|
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).
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16 weeks
|
Weight maintenance (Percent Body Fat)
Time Frame: 16 weeks
|
Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.
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16 weeks
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Weight maintenance (Body Mass Index)
Time Frame: 16 weeks
|
Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.
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16 weeks
|
Weight maintenance (Waist Circumference)
Time Frame: 16 weeks
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Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.
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16 weeks
|
Change from baseline Moderate-to-vigorous physical activity (MVPA)
Time Frame: 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.
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40 weeks
|
Weight maintenance (Waist Circumference)
Time Frame: 40 weeks
|
Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.
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40 weeks
|
Weight maintenance (Body Mass Index)
Time Frame: 40 weeks
|
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
Time Frame: 40 weeks
|
The 2-minute step in place test will be used to assess cardiorespiratory fitness (steps/minute).
|
40 weeks
|
Weight maintenance (Percent Body Fat)
Time Frame: 40 weeks
|
Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.
|
40 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Deborah M Parra-Medina, PhD, UT Health San Antonio
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
January 22, 2014
First Submitted That Met QC Criteria
January 23, 2014
First Posted (Estimate)
January 27, 2014
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- HSC20110460H
- R01HL111718 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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