Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-technology MVPA intervention.
- Who it may be relevant to
- Registry conditions: Physical Activity. Basic parameters: 13 years — 17 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral Multi-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.
Primary outcome measures
- Meeting guidelines for physical activity [Time frame: 6 months]
Secondary outcome measures (12)
- Maintenance of MVPA [Time frame: 12 months]
- Processes of Change for Physical Activity (POC) [Time frame: 12 months]
- Stages of Change for Physical Activity (SCPA) [Time frame: 12 months]
- Self-Efficacy for Physical Activity (SE) [Time frame: 12 months]
- Social Support for Exercise (SSE) [Time frame: 12 months]
- Outcome Expectations Scale [Time frame: 12 months]
- Technology Engagment [Time frame: 12 months]
- Neighborhood Environment Walkability Scale for Youth (NEWS-Y) [Time frame: Baseline]
- Vital Signs [Time frame: 12 months]
- Perceived Stress Scale (PSS) [Time frame: 12 months]
- Demographics [Time frame: Baseline]
- Physical Activity Enjoyment Scale (PACES) [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California- San Diego — La Jolla
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. PMID 34128823
Identifiers
NCT: NCT06595056 · 810268 · R01HL171807