NCT06768801

Brief Summary

The purpose of the proposed project is to conduct a pilot randomized controlled trial (RCT) of the Web-App based Lifestyle Physical Activity Promotion Program (WPAPP) for middle-aged Latinas. The WPAPP is a web application (app) to promote lifestyle physical activity that was developed and tested with Korean American middle aged women. It shows promise for effectiveness with Latinas. The specific aims are:

  1. 1.To test the feasibility and satisfaction of the WPAPP modified for Latinas.
  2. 2.To examine preliminary effectiveness of the WPAPP-Latina on increasing physical activity and decreasing depressive symptoms.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 6, 2025

Last Update Submit

January 6, 2025

Conditions

Keywords

Web-based App

Outcome Measures

Primary Outcomes (5)

  • Center for Epidemiological Studies - Depression

    20-item measure of frequency and quantity of depressive symptoms

    from baseline to 3 months

  • The modified Barriers to Health Activities Scale

    16 items scored as 1= never to 4= routinely) about barriers to regular physical activity. Each item asks the women to identify the frequency of interferences with their regular physical activity due to the issue in the individual item. All items will be summed to calculate a total score.

    from baseline to 3 months

  • Kaiser Physical Activity Survey

    Quantity of Physical Activity

    from baseline to 3 months

  • Questions on Attitudes Toward Physical Activity, Subjective Norm, Perceived Behavioral Control, and Behavioral Intention

    The scale is four domains of physical activity; the Attitudes Toward Physical Activity, Subjective Norm, Perceived Behavioral Control, but only the items in the attitude and social influences domains will be used in this study. The attitude domain has six bipolar (-3 to +3) semantic differential scale items. The social influences domain has three unipolar (1 to 7) scale items.

    from baseline to 3 months

  • Physical Activity Assessment Inventory

    13 items measuring self-efficacy related to physical activity in diverse conditions scored from 0= cannot do at all to 100= certainly can do.

    from baseline to 3 months

Study Arms (1)

WPAPP-Latina Intervention

EXPERIMENTAL
Behavioral: WPAPP-Latina

Interventions

WPAPP-LatinaBEHAVIORAL

The WPAPP Latina intervention provides 1) educational information via modules and online resources and 2) coaching via an online forum with a chat function. The educational modules include 11 modules on physical activity promotion and 7 modules on depressive symptoms. The women are also invited to share their experiences with culturally matched interventionists (e.g., Spanish speaking graduate research assistant with expertise in depressive symptoms and physical activity) and with peer participants using a de-identified name in the online chat forum. Participants will be directed to information about physical activity with age-appropriate guidelines from the Centers for Disease Control and Prevention.

WPAPP-Latina Intervention

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as a woman
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Alexandra Garcia, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Two group (intervention and control), random assignment, 3 data collection points
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 10, 2025

Study Start

March 1, 2025

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01