Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2

NCT06595056 | Enrolling By Invitation

• 2 other identifiers: 810268R01HL171807
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test a physical activity intervention for Latina teenagers. Investigators will recruit 200 Latina adolescents who are currently under-active to participate in this 12-month study. Participants will be referred to the study by their primary care provider. Half of the participants will be randomly selected for the Intervention group, and will receive an individual counseling session and access to a personalized website. These participants will also receive a Fitbit activity tracker to help with goal setting and monitoring, plus weekly text messages and access to the study Instagram account to remind participants to be physically active. Those assigned to the control group will receive the Fitbit activity tracker.

Conditions

Physical Activity

Keywords

adolescent health; Latina; teenager; mHealth; fitness tracker

Outcome Measures

Primary Outcomes (1)

• Meeting guidelines for physical activity

  Proportion of participants meeting guidelines of 60 min/day of moderate to vigorous physical activity (MVPA) measured by Fitbits

  6 months

Secondary Outcomes (13)

• Maintenance of MVPA

  12 months

• Processes of Change for Physical Activity (POC)

  12 months

• Stages of Change for Physical Activity (SCPA)

  12 months

• Self-Efficacy for Physical Activity (SE)

  12 months

• Social Support for Exercise (SSE)

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive a one-on-one counseling session and access to an individually tailored multi-media website. Key intervention components will be reinforced through text messaging to aid goal setting, a physical activity tracker (Fitbit) to set goals, track and log activity, and access to a study Instagram account to reinforce exposure to web content.

Behavioral: Multi-technology MVPA intervention

Control

NO INTERVENTION

Participants will receive a physical activity tracker (Fitbit) only.

Interventions

Multi-technology MVPA intervention BEHAVIORAL

Participants will receive a one-on-one counseling session and access to an individually tailored multi-media website. Key intervention components will be reinforced through text messaging to aid goal setting, a physical activity tracker (Fitbit) to set goals, track and log activity, and access to a study Instagram account to reinforce exposure to web content.

Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• self identify as Latina
• age 13-17
• read, write, and speak English
• be a current patient at FHCSD
• be under-active (engaging in 60 min/day of MVPA on fewer than 5 days per week)
• regular access (≥2 times/week) to Internet and a smart phone that can receive text messages

You may not qualify if:

• unwillingness to be randomized to one of the two conditions
• self-reporting any condition that would impair ability to participate in physical activity for at least 10 minutes at a time

Sponsors & Collaborators

• Family Health Centers of San Diego: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of California, San Diego: lead

Study Sites (1)

University of California- San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Larsen B, Greenstadt ED, Olesen BL, Marcus BH, Godino J, Zive MM. An mHealth Physical Activity Intervention for Latina Adolescents: Iterative Design of the Chicas Fuertes Study. JMIR Form Res. 2021 Jun 15;5(6):e26195. doi: 10.2196/26195.

  PMID: 34128823 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 7 years after the end of the funding period.
• Access Criteria: The Larsen USCD data provides metadata, persistent identifiers and long-term access. This repository is supported by USCD and dataset(s) are available through a request process directly with the PI, Dr. Larsen.

Locations

US (1)