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Physical ActivityNCT06595056

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

A study testing Multi-technology MVPA intervention in people with Physical Activity, run by University of California, San Diego at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 years, women only
Conditions the study is for
Physical Activity
What is being tested?
Multi-technology MVPA intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
10 Apr 2025to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of California- San Diego

    La Jolla, California, 92093

Other trials in United States

About this study

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.

Read the detailed description

This study will conduct a randomized trial to evaluate the efficacy of a theory-based, individually tailored, multi-technology intervention on increasing physical activity in Latina adolescents, compared to a control group receiving only a physical activity tracker (a Fitbit). The study team will recruit adolescent (age 13-17) Latinas (N=200) who are currently under-active to participate in the 12-month trial. Those randomized to the Intervention arm 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. The primary outcome will be increases in moderate-to-vigorous activity between baseline and 6 months. Secondary outcomes will include changes in activity at 12 months, potential mediators of the intervention, costs of delivering the intervention, behavior change trajectories from continuous data from Fitbits, potential moderators, and changes in physiological and psychological variables.

Being tested
Multi-technology MVPA intervention
Keywords
adolescent health, Latina, teenager, mHealth, fitness tracker
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-technology MVPA interventionBehavioural

    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.

Study groups in NCT06595056
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Multi-technology MVPA intervention
ControlNo interventionParticipants will receive a physical activity tracker (Fitbit) only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (16)

  1. Maintenance of MVPA

    Proportion of participants meeting guidelines of 60 minutes/day of MVPA measured by Fitbits.

    Measured: 12 months

  2. Processes of Change for Physical Activity (POC)

    Questionnaire that tracks cognitive and behavioral processes related to MVPA change

    Measured: 12 months

  3. Stages of Change for Physical Activity (SCPA)

    Questionnaire that determines what stage of exercise engagement the participant is currently in (precontemplation, contemplation, preparation, action, maintenance), and is used to stage-match treatment.

    Measured: 12 months

  4. Self-Efficacy for Physical Activity (SE)

    Questionnaire that measures self-efficacy to become physically active across diverse contexts

    Measured: 12 months

  5. Social Support for Exercise (SSE)

    Questionnaire measuring social support specifically in relation to exercise with three subscales (friends, family, rewards/punishments)

    Measured: 12 months

  6. Outcome Expectations Scale

    Questionnaire that measures the beliefs regarding the consequences of physical activity participation

    Measured: 12 months

  7. Technology Engagment

    Tracks activity on the study website (logins, goal setting, questionnaires answered), Fitbit activity (days worn, sync frequency), texting activity (% of interactive texts responded to), Instagram activity (views, likes)

    Measured: 12 months

  8. Physical Activity Neighborhood Environment Survey (PANES)

    Questionnaire that measures perceptions of neighborhood environment regarding walking and bicycling.

    Measured: 12 months

  9. Vital Signs

    Height, weight, resting blood pressure

    Measured: 12 months

  10. Perceived Stress Scale (PSS)

    Questionnaire used to assess stress levels

    Measured: 12 months

  11. Demographics

    Age, race, parent education and income, marital status, acculturation

    Measured: Baseline

  12. Physical Activity Enjoyment Scale (PACES)

    Questionnaire that assesses level of personal satisfaction from physical activity

    Measured: 12 months

  13. Patient Health Questionnaire for Adolescents (PHQ A)

    Questionnaire that assesses the degree of depression severity. Scores range from 0 to 27, with higher scores indicating more severe symptoms.

    Measured: 12 months

  14. Dysmorphic Concern Questionnaire (DCQ)

    Measures a person's degree of body image concern. Scores range from 0 to 21, with higher scores indicating greater preoccupation/anxiety with physical appearance.

    Measured: 12 months

  15. International Physical Activity Questionnaire Short Form (IPAQ-SF)

    A survey used to measure physical activity and sedentary behavior

    Measured: 12 months

  16. Satisfaction Survey

    Questionnaire that measures a study participant's satisfaction with various study components as well as their overall experience in the study

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start10 Apr 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06595056
Sponsor's protocol ID
810268
Other IDs
R01HL171807
Status last verified
Aug 2026
First submitted
6 Sep 2024
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All quantitative data produced in the course of the project will be preserved and shared. Transcripts from stakeholder interviews will be shared only in the event that they give permission for the entire transcript to be shared; otherwise, summaries and codebooks will be shared.

Publications

  • 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.

    PubMed 34128823

Questions about this trial

What is this clinical trial studying?

A study testing Multi-technology MVPA intervention in people with Physical Activity, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Meeting guidelines for physical activity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06595056, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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