Clinical trial NCT06595056: Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2
Official title: Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Physical Activity
Keywords: adolescent health
Latina
teenager
mHealth
fitness tracker
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Family Health Centers of San Diego
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Meeting guidelines for physical activity
timeFrame: 6 months
Secondary outcomes:
measure: Maintenance of MVPA
timeFrame: 12 months
measure: Processes of Change for Physical Activity (POC)
timeFrame: 12 months
measure: Stages of Change for Physical Activity (SCPA)
timeFrame: 12 months
measure: Self-Efficacy for Physical Activity (SE)
timeFrame: 12 months
measure: Social Support for Exercise (SSE)
timeFrame: 12 months
measure: Outcome Expectations Scale
timeFrame: 12 months
measure: Technology Engagment
timeFrame: 12 months
measure: Neighborhood Environment Walkability Scale for Youth (NEWS-Y)
timeFrame: Baseline
measure: Vital Signs
timeFrame: 12 months
measure: Perceived Stress Scale (PSS)
timeFrame: 12 months
measure: Demographics
timeFrame: Baseline
measure: Physical Activity Enjoyment Scale (PACES)
timeFrame: 12 months
measure: Childrens Depression Inventory (CDI)
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California- San Diego
state: California
Study officials:
References:
citation: 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.