NCT03491592

Brief Summary

This renewal builds upon our successful culturally adapted PA intervention for Latinas (Pasos Hacia La Salud, R01CA159954) and expands its focus to the critical area of maintenance of behavior change. This study will test an enhanced version of the original internet intervention in order to achieve greater increases in PA and longer term maintenance. Investigators propose to test this newly developed enhanced intervention (Enhanced Intervention) compared to the original Pasos Hacia La Salud Intervention (Original Intervention) in a 24-month randomized trial (N=300).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

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

First Submitted

Initial submission to the registry

March 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

3.8 years

First QC Date

March 26, 2018

Last Update Submit

February 21, 2023

Conditions

Inactivity

Keywords

Physical ActivityLatinasSpanish-languageText-MessageExerciseWeb-based

Outcome Measures

Primary Outcomes (1)

  • Change in total weekly minutes of physical activity as measured by an accelerometer

    For the week prior to each assessment, participants will wear an Actigraph GT3X+ accelerometer which collects min/week of objectively measured MVPA.

    Baseline, 6 months, 12, 18 and 24 months

Study Arms (2)

Enhanced Physical Activity Intervention

EXPERIMENTAL

A data driven enhanced Pasos Hacia La Salud intervention based on results and participant feedback from the motivationally-tailored, Spanish Language, Internet-based Physical Activity intervention in the parent study.

Behavioral: Enhanced Physical Activity Intervention

Original Physical Activity Intervention

ACTIVE COMPARATOR

The original Internet-based program is a computer expert system-driven, individually tailored Spanish language intervention, guided by Social Cognitive Theory (SCT) and the Transtheoretical Model (TTM).

Behavioral: Original Physical Activity Intervention

Interventions

Enhanced Physical Activity InterventionBEHAVIORAL

Participants in the Enhanced Intervention arm will receive all the intervention components of the Original Intervention described above plus: 1) text messages and adaptive goal-setting to drive participants back to the website and keep them there longer, and 2) data-driven, technology supported enhanced intervention content targeting theoretical constructs that influenced PA behavior in Latinas from the parent study.

Enhanced Physical Activity Intervention
Original Physical Activity InterventionBEHAVIORAL

Participants in the Original Physical Activity intervention arm of the study will receive the original Spanish language, motivationally-tailored, Internet-based physical activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.

Original Physical Activity Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Generally healthy (If asthma and/or high blood pressure, may be able to participate with physician consent)
  • Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
  • Self-identify as Hispanic or Latino (or of a group defined as Hispanic/Latino by the Census Bureau
  • Must be able to read and write Spanish fluently
  • years of age
  • Daily access to a text-message compatible cell phone and to an Internet-connected device through home, work, or their community

You may not qualify if:

  • History of coronary heart disease (history of myocardial infarction or symptoms of angina),
  • Diabetes that requires insulin and does not have a doctor's approval
  • Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval
  • Orthopedic conditions which limit mobility, any other serious medical condition that would make PA unsafe (based on modified Physical Activity Readiness Questionnaire)
  • Hospitalization due to a psychiatric disorder in the past 3 years
  • BMI above 45 kg/m2
  • Current or planned pregnancy in the next two year
  • Moving from area within two years
  • Does not have a cellphone capable of sending and receiving text messages
  • Not able to receive materials in the mail, either at your own home or at a mailbox

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

121 South Main Street, Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (4)

  • Larsen B, Pekmezi D, Hartman SJ, Dunsiger S, Gilmer T, Groessl E, Marcus B. Costs and Cost-Effectiveness at 12 and 24 Months of an Enhanced Web-Based Physical Activity Intervention for Latina Adults: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2025 Nov 25;27:e76739. doi: 10.2196/76739.

    PMID: 41289583DERIVED

  • Connell Bohlen L, Dunsiger SI, von Ash T, Larsen BA, Pekmezi D, Marquez B, Benitez TJ, Mendoza-Vasconez A, Hartman SJ, Williams DM, Marcus BH. Six-Month Outcomes of a Theory- and Technology-Enhanced Physical Activity Intervention for Latina Women (Pasos Hacia La Salud II): Randomized Controlled Trial. J Med Internet Res. 2024 Jun 6;26:e51708. doi: 10.2196/51708.

    PMID: 38842930DERIVED

  • von Ash T, Dunsiger SI, Williams DM, Larsen BA, Bohlen LC, Pekmezi D, Mendoza-Vasconez AS, Benitez TJ, Bock BC, Hartman SJ, Marquez B, Marcus BH. Pasos Hacia La Salud II: A Superiority RCT Utilizing Technology to Promote Physical Activity in Latinas. Am J Prev Med. 2024 Aug;67(2):220-230. doi: 10.1016/j.amepre.2024.03.006. Epub 2024 Mar 13.

    PMID: 38490284DERIVED

  • Mendoza-Vasconez AS, Benitez T, Dunsiger S, Gans KM, Hartman SJ, Linke SE, Larsen BA, Pekmezi D, Marcus BH. Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention. Trials. 2022 Aug 1;23(1):621. doi: 10.1186/s13063-022-06575-4.

    PMID: 35915473DERIVED

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Behavioral and Social Sciences, Brown University School of Public Health

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 9, 2018

Study Start

June 1, 2018

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

US(1)