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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06595056
Enrollment
200
Registered
2024-09-19
Start date
2025-04-10
Completion date
2029-06-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

adolescent health, Latina, teenager, mHealth, fitness tracker

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.

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.

Interventions

BEHAVIORALMulti-technology MVPA intervention

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.

Sponsors

University of California, San Diego
Lead SponsorOTHER
Family Health Centers of San Diego
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Meeting guidelines for physical activity6 monthsProportion of participants meeting guidelines of 60 min/day of moderate to vigorous physical activity (MVPA) measured by Fitbits

Secondary

MeasureTime frameDescription
Maintenance of MVPA12 monthsProportion of participants meeting guidelines of 60 minutes/day of MVPA measured by Fitbits.
Processes of Change for Physical Activity (POC)12 monthsQuestionnaire that tracks cognitive and behavioral processes related to MVPA change
Stages of Change for Physical Activity (SCPA)12 monthsQuestionnaire that determines what stage of exercise engagement the participant is currently in (precontemplation, contemplation, preparation, action, maintenance), and is used to stage-match treatment.
Self-Efficacy for Physical Activity (SE)12 monthsQuestionnaire that measures self-efficacy to become physically active across diverse contexts
Social Support for Exercise (SSE)12 monthsQuestionnaire measuring social support specifically in relation to exercise with three subscales (friends, family, rewards/punishments)
Outcome Expectations Scale12 monthsQuestionnaire that measures the beliefs regarding the consequences of physical activity participation
Technology Engagment12 monthsTracks 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)
Physical Activity Neighborhood Environment Survey (PANES)12 monthsQuestionnaire that measures perceptions of neighborhood environment regarding walking and bicycling.
Vital Signs12 monthsHeight, weight, resting blood pressure
Perceived Stress Scale (PSS)12 monthsQuestionnaire used to assess stress levels
DemographicsBaselineAge, race, parent education and income, marital status, acculturation
Physical Activity Enjoyment Scale (PACES)12 monthsQuestionnaire that assesses level of personal satisfaction from physical activity
Patient Health Questionnaire for Adolescents (PHQ A)12 monthsQuestionnaire that assesses the degree of depression severity. Scores range from 0 to 27, with higher scores indicating more severe symptoms.
Dysmorphic Concern Questionnaire (DCQ)12 monthsMeasures a person's degree of body image concern. Scores range from 0 to 21, with higher scores indicating greater preoccupation/anxiety with physical appearance.
International Physical Activity Questionnaire Short Form (IPAQ-SF)12 monthsA survey used to measure physical activity and sedentary behavior
Satisfaction Survey12 monthsQuestionnaire that measures a study participant's satisfaction with various study components as well as their overall experience in the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026