Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

Physical Activity Clinical Trial

Official title:

ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046343
• Other study ID #: HSC20110460H
• Secondary ID: R01HL111718
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2018
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center San Antonio	San Antonio	Texas

Sponsors (7)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Heart, Lung, and Blood Institute (NHLBI), Texas A&M University, Texas Tech University Health Sciences Center, El Paso, The University of Texas Health Science Center, Houston, University of Maryland, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Secondary	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).	16 weeks
Secondary	Weight maintenance (Percent Body Fat)	Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.	16 weeks
Secondary	Weight maintenance (Body Mass Index)	Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.	16 weeks
Secondary	Weight maintenance (Waist Circumference)	Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.	16 weeks
Secondary	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.	40 weeks
Secondary	Weight maintenance (Waist Circumference)	Weight maintenance is defined as a change in waist circumference less than ± 3% of baseline.	40 weeks
Secondary	Weight maintenance (Body Mass Index)	Weight maintenance is defined as a change in body mass index (kg/m2) less than ± 3% of baseline.	40 weeks
Secondary	Change from baseline in Physical Fitness	The 2-minute step in place test will be used to assess cardiorespiratory fitness (steps/minute).	40 weeks
Secondary	Weight maintenance (Percent Body Fat)	Weight maintenance is defined as a change in % body fat less than ± 3% of baseline.	40 weeks

External Links

•   Institute for Health Promotion Research Website