NCT02046343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
712

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4.4 years

First QC Date

January 22, 2014

Last Update Submit

August 28, 2018

Conditions

Physical Activity

Keywords

physical activitypreventionhealth disparitiesbehaviorcommunity based intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change from baseline in Physical Fitness

    16 weeks

  • Weight maintenance (Percent Body Fat)

    16 weeks

  • Weight maintenance (Body Mass Index)

    16 weeks

  • Weight maintenance (Waist Circumference)

    16 weeks

  • Change from baseline Moderate-to-vigorous physical activity (MVPA)

    40 weeks

  • +4 more secondary outcomes

Study Arms (2)

Physical Activity

EXPERIMENTAL

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 educationBehavioral: Telephone CounselingOther: NewsletterOther: Environmental Change

Community Health and Safety

PLACEBO COMPARATOR

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

Interventions

Health educationBEHAVIORAL

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.

Community Health and SafetyPhysical Activity
Telephone CounselingBEHAVIORAL

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.

Physical Activity
NewsletterOTHER

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

Physical Activity
Environmental ChangeOTHER

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

Physical Activity

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • 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.

    PMID: 31221117DERIVED

Related Links

MeSH Terms

Conditions

Motor ActivityBehavior

Study Officials

  • Deborah M Parra-Medina, PhD

    UT Health San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 27, 2014

Study Start

August 1, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

US(1)