Physical ActivityNCT04190225
Physical Activity Intervention for Adolescent Girls
A study testing Digital/social media intervention in people with Physical Activity, run by University of California, San Diego at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Digital/social media intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 24 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- self identify as Latina
- 13-18 years old
- read, write, speak English
- under active (participating in <150 minutes of moderate to vigorous physical activity per week)
- regular access to the Internet (at least 2 times per week)
- regular access to a cell phone that can send and receive text messages
Who cannot join
- inability to safely engage in physical activity, as determined by the Physical Activity Readiness Questionnaire
- BMI > 45
- Plan to move from the area within 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Individually Tailored Physical Activity Intervention for Latina Adolescents: Chicas Fuertes
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 investigators will recruit adolescent (age 13-18) Latinas (N=200) who are currently underactive 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.
Read the detailed description
Latina adolescents report low levels of physical activity, with only 3% meeting national physical activity guidelines, and are at high lifetime risk for conditions related to inactivity, such as obesity, metabolic syndrome, and diabetes. Interventions grounded in sound psychosocial theory and leveraging growing technology use in Latina adolescents are needed to reverse patterns of inactivity, establish healthy lifetime habits and reduce widening disparities. The research team has developed and tested individually tailored, culturally adapted web-based interventions to increase moderate-to-vigorous physical activity (MVPA) for Latinos, which significantly increased MVPA in adult Latino men and women. In a recent pilot study (R03NR014329), this intervention was adapted based on formative interviews to make it appropriate for Latina adolescents and tested it in a single-arm pilot trial (N=21). After 12 weeks, retention was high (90.5%) and self-reported MVPA increased from 24.7(26.11) minutes/week at baseline to 79.4(46.8) at follow up (p<0.001), suggesting good potential efficacy. In closeout interviews, girls expressed a preference to increase audiovideo components of the website and to incorporate other mobile-health technologies, such as texting, smartphone apps, social media, and wearables. Thus, the aim of this study is to conduct a randomized controlled trial (N=200) of an individually tailored, theory-based, multi-technology intervention to increase MVPA in Latina adolescents. The intervention will comprise a counseling session to teach behavior change techniques, an interactive multimedia website with individually tailored content based on principles of the Transtheoretical Model and Social Cognitive Theory, a wearable tracker and smartphone app to reinforce key behavior change techniques, connection with a study Instagram account to reinforce exposure to intervention content, and automated text messages guide continued goal setting. Participants will be randomly assigned to receive the intervention or only a wearable tracker with smartphone app. Activity will be measured at baseline and six-month follow-up using well-established MVPA measures (accelerometers and the 7-Day Physical Activity Recall Interview). It is hypothesized that those randomized to receive the intervention will show significantly greater increases in MVPA at six months than those in the control group. The investigators will also evaluate whether changes in MVPA are mediated by changes in targeted psychosocial constructs (e.g. self-efficacy, social support) or engagement with technology, assess longer-term changes in MVPA at 12 months, and evaluate whether intervention effects are moderated by baseline personal and environmental variables (e.g. age, BMI, neighborhood environment). Costs to deliver the intervention (e.g. staff time, materials, overhead) will be tracked to evaluate costs and cost-effectiveness of both study arms, and the investigators will track contact time to assess whether staff contact is related to study outcomes. The investigators will also explore trajectories of daily activity in both the intervention and control groups using continuous data from wearable trackers. The proposed study will promote a critical preventive health behavior, physical activity, in Latina adolescents using technologies that are pervasive in this high risk, quickly growing population and highly scalable, laying the groundwork for cost-effective, broad reaching interventions with great potential for preventing chronic disease and promoting health and wellbeing throughout the lifespan.
- Conditions
- Physical Activity
- Being tested
- Digital/social media intervention
- Keywords
- physical activity, adolescents, teenagers, Latina
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital/social media interventionBehavioural
Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
| Study group | Role | What they receive |
|---|---|---|
| Multi-technology physical activity intervention | Experimental | Digital/social media Receives: Behavioral: Digital/social media intervention |
| Control | No intervention | Control group receives a Fitbit but none of the intervention components. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively Measured Weekly Minutes of Activity
The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months. (waking hours only) to measure movement and intensity of activity
Measured: Baseline, 6 Months (MO)
Self-Reported Weekly Minutes of Activity
The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from baseline to 6 months. The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
Measured: Baseline, 6 Months (MO)
Secondary outcomes (1)
Objectively Measured Weekly Minutes Minutes of Activity
weekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start6 Aug 2020
- Primary completion21 Nov 2023
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 1:1 treatment: control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Brown University
- Responsible party
- Principal investigator, Britta Larsen, University of California, San Diego
- Investigators
- Britta Larsen, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190225
- Sponsor's protocol ID
- 182070
- Other IDs
- R01NR017876
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2019
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castro E, Carson J, Greenstadt E, Olivera B, Dunsiger S, Higgins M, Godino J, Marcus B, Meyer D, Zive M, Larsen B. Maintenance of physical activity gains among Latina teens: 12-month findings from the Chicas Fuertes randomized controlled trial. Int J Behav Nutr Phys Act. 2026 May 29. doi: 10.1186/s12966-026-01933-w. Online ahead of print.
PubMed 42215952Carson JR, Greenstadt E, Olivera B, Dunsiger S, Zive M, Higgins M, Godino J, Marcus B, Meyer D, Larsen B. A Multiple Technology-Based Physical Activity Intervention for Latina Adolescents: Results From the Chicas Fuertes Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Dec 11;13:e71623. doi: 10.2196/71623.
PubMed 41380028Larsen B, Greenstadt E, Olesen B, Osuna L, Godino J, Marcus B, Dunsiger S, Meyer D, Zive M. A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes. Trials. 2022 Feb 23;23(1):176. doi: 10.1186/s13063-022-06105-2.
PubMed 35197106
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Physical Activity Intervention for Latina Adolescents: Chicas Fuertes
- ClinicalTrials.gov ID
- NCT04190225
- Acronym / sponsor ID
- 182070
- Conditions
- Physical Activity
- Keywords
- physical activity, adolescents, teenagers, Latina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Brown University
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 investigators will recruit adolescent (age 13-18) Latinas (N=200) who are currently underactive 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.
Detailed description
Latina adolescents report low levels of physical activity, with only 3% meeting national physical activity guidelines, and are at high lifetime risk for conditions related to inactivity, such as obesity, metabolic syndrome, and diabetes. Interventions grounded in sound psychosocial theory and leveraging growing technology use in Latina adolescents are needed to reverse patterns of inactivity, establish healthy lifetime habits and reduce widening disparities. The research team has developed and tested individually tailored, culturally adapted web-based interventions to increase moderate-to-vigorous physical activity (MVPA) for Latinos, which significantly increased MVPA in adult Latino men and women. In a recent pilot study (R03NR014329), this intervention was adapted based on formative interviews to make it appropriate for Latina adolescents and tested it in a single-arm pilot trial (N=21). After 12 weeks, retention was high (90.5%) and self-reported MVPA increased from 24.7(26.11) minutes/week at baseline to 79.4(46.8) at follow up (p<0.001), suggesting good potential efficacy. In closeout interviews, girls expressed a preference to increase audiovideo components of the website and to incorporate other mobile-health technologies, such as texting, smartphone apps, social media, and wearables. Thus, the aim of this study is to conduct a randomized controlled trial (N=200) of an individually tailored, theory-based, multi-technology intervention to increase MVPA in Latina adolescents. The intervention will comprise a counseling session to teach behavior change techniques, an interactive multimedia website with individually tailored content based on principles of the Transtheoretical Model and Social Cognitive Theory, a wearable tracker and smartphone app to reinforce key behavior change techniques, connection with a study Instagram account to reinforce exposure to intervention content, and automated text messages guide continued goal setting. Participants will be randomly assigned to receive the intervention or only a wearable tracker with smartphone app. Activity will be measured at baseline and six-month follow-up using well-established MVPA measures (accelerometers and the 7-Day Physical Activity Recall Interview). It is hypothesized that those randomized to receive the intervention will show significantly greater increases in MVPA at six months than those in the control group. The investigators will also evaluate whether changes in MVPA are mediated by changes in targeted psychosocial constructs (e.g. self-efficacy, social support) or engagement with technology, assess longer-term changes in MVPA at 12 months, and evaluate whether intervention effects are moderated by baseline personal and environmental variables (e.g. age, BMI, neighborhood environment). Costs to deliver the intervention (e.g. staff time, materials, overhead) will be tracked to evaluate costs and cost-effectiveness of both study arms, and the investigators will track contact time to assess whether staff contact is related to study outcomes. The investigators will also explore trajectories of daily activity in both the intervention and control groups using continuous data from wearable trackers. The proposed study will promote a critical preventive health behavior, physical activity, in Latina adolescents using technologies that are pervasive in this high risk, quickly growing population and highly scalable, laying the groundwork for cost-effective, broad reaching interventions with great potential for preventing chronic disease and promoting health and wellbeing throughout the lifespan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 treatment: control
| Arm | Type | Receives |
|---|---|---|
| Multi-technology physical activity intervention | Experimental | Behavioral: Digital/social media interventionDigital/social media |
| Control | No intervention | –Control group receives a Fitbit but none of the intervention components. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- self identify as Latina
- 13-18 years old
- read, write, speak English
- under active (participating in <150 minutes of moderate to vigorous physical activity per week)
- regular access to the Internet (at least 2 times per week)
Key exclusion criteria (3 listed)
- inability to safely engage in physical activity, as determined by the Physical Activity Readiness Questionnaire
- BMI > 45
- Plan to move from the area within 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital/social media interventionParticipants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit) | Behavioural | Multi-technology physical activity intervention |
Primary outcome
Objectively Measured Weekly Minutes of Activity
Time frame: Baseline, 6 Months (MO)
The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months. (waking hours only) to measure movement and intensity of activity
Self-Reported Weekly Minutes of Activity
Time frame: Baseline, 6 Months (MO)
The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from baseline to 6 months. The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
1 secondary outcome
Objectively Measured Weekly Minutes Minutes of Activity
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42215952Castro E, Carson J, Greenstadt E, Olivera B, Dunsiger S, Higgins M, Godino J, Marcus B, Meyer D, Zive M, Larsen B. Maintenance of physical activity gains among Latina teens: 12-month findings from the Chicas Fuertes randomized controlled trial. Int J Behav Nutr Phys Act. 2026 May 29. doi: 10.1186/s12966-026-01933-w. Online ahead of print.
- Derived from this study: PubMed 41380028Carson JR, Greenstadt E, Olivera B, Dunsiger S, Zive M, Higgins M, Godino J, Marcus B, Meyer D, Larsen B. A Multiple Technology-Based Physical Activity Intervention for Latina Adolescents: Results From the Chicas Fuertes Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Dec 11;13:e71623. doi: 10.2196/71623.
- Derived from this study: PubMed 35197106Larsen B, Greenstadt E, Olesen B, Osuna L, Godino J, Marcus B, Dunsiger S, Meyer D, Zive M. A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes. Trials. 2022 Feb 23;23(1):176. doi: 10.1186/s13063-022-06105-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britta Larsen, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital/social media 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 3 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objectively Measured Weekly Minutes of Activity (time frame: Baseline, 6 Months (MO)). The study lists 2 primary outcomes in all. 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 NCT04190225, which also lists 3 linked publications.
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 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.