Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

NCT ID: NCT02046343

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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 Type EXPERIMENTAL

Health education

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.

Environmental Change

Intervention Type OTHER

Create a site atmosphere that promotes PA and increases the number of PA program offerings.

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.

Group Type PLACEBO_COMPARATOR

Health education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Newsletter

Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.

Intervention Type OTHER

Environmental Change

Create a site atmosphere that promotes PA and increases the number of PA program offerings.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role collaborator

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role collaborator

University of Maryland

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Deborah Parra-Medina

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah M Parra-Medina, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Locations

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University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31221117 (View on PubMed)

Related Links

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https://ihpr.uthscsa.edu/project/14

Institute for Health Promotion Research Website

Other Identifiers

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R01HL111718

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20110460H

Identifier Type: -

Identifier Source: org_study_id

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