Clinical trial NCT02046343: Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
Official title: ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
prevention
health disparities
behavior
community based intervention
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of South Carolina
name: The University of Texas Health Science Center, Houston
name: Texas A&M University
name: Texas Tech University Health Sciences Center, El Paso
name: University of Maryland
First posted: 2014-01-27
Enrollment: 712
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Moderate-to-vigorous physical activity (MVPA)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change from baseline in Physical Fitness
timeFrame: 16 weeks
measure: Weight maintenance (Percent Body Fat)
timeFrame: 16 weeks
measure: Weight maintenance (Body Mass Index)
timeFrame: 16 weeks
measure: Weight maintenance (Waist Circumference)
timeFrame: 16 weeks
measure: Change from baseline Moderate-to-vigorous physical activity (MVPA)
timeFrame: 40 weeks
measure: Weight maintenance (Waist Circumference)
timeFrame: 40 weeks
measure: Weight maintenance (Body Mass Index)
timeFrame: 40 weeks
measure: Change from baseline in Physical Fitness
timeFrame: 40 weeks
measure: Weight maintenance (Percent Body Fat)
timeFrame: 40 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Deborah M Parra-Medina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salinas JJ, Parra-Medina D. Physical activity change after a promotora-led intervention in low-income Mexican American women residing in South Texas. BMC Public Health. 2019 Jun 20;19(1):782. doi: 10.1186/s12889-019-7105-6.