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Enrolling by Invitation

NCT Number: NCT06595056

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

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.

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Key information

Age range

13 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California- San Diego

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Meeting guidelines for physical activity

    Time frame: 6 months

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

Secondary outcomes

  1. Maintenance of MVPA

    Time frame: 12 months

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

  2. Processes of Change for Physical Activity (POC)

    Time frame: 12 months

    Questionnaire that tracks cognitive and behavioral processes related to MVPA change

  3. Stages of Change for Physical Activity (SCPA)

    Time frame: 12 months

    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.

  4. Self-Efficacy for Physical Activity (SE)

    Time frame: 12 months

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

  5. Social Support for Exercise (SSE)

    Time frame: 12 months

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

  6. Outcome Expectations Scale

    Time frame: 12 months

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

  7. Technology Engagment

    Time frame: 12 months

    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)

  8. Neighborhood Environment Walkability Scale for Youth (NEWS-Y)

    Time frame: Baseline

    Questionnaire that measures perceptions of neighborhood environment including recreation facility availability, pedestrian traffic safety, and walking facilities

  9. Vital Signs

    Time frame: 12 months

    Height, weight, resting blood pressure

  10. Perceived Stress Scale (PSS)

    Time frame: 12 months

    Questionnaire used to assess stress levels

  11. Demographics

    Time frame: Baseline

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

  12. Physical Activity Enjoyment Scale (PACES)

    Time frame: 12 months

    Questionnaire that assesses level of personal satisfaction from physical activity

  13. Patient Health Questionnaire for Adolescents (PHQ A)

    Time frame: 12 months

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

  14. Dysmorphic Concern Questionnaire (DCQ)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Family Health Centers of San Diego
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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