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Physical Activity Intervention for Adolescent Girls
NA trial testing Digital/social media intervention in Physical Activity in 160 participants. Completed in 24 May 2024.
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 160 |
| Start date | 6 August 2020 |
| Primary completion | 21 November 2023 |
| Estimated completion | 24 May 2024 |
| Sites | 1 location across United States |
University of California, San Diego
Adults 13 to 18, female only, with Physical Activity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Multi-technology Physical Activity Intervention | 64 | 19 – 72 |
| Control | 41 | 7 – 76 |
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
| Group | Value | 95% CI |
|---|---|---|
| Multi-technology Physical Activity Intervention | 147 | 96 – 181 |
| Control | 124 | 100 – 169 |
weekly minutes of moderate-to-vigorous physical activity measured by ActiGraph accelerometer
| Group | Value | 95% CI |
|---|---|---|
| Multi-technology Physical Activity Intervention | 74 | 32 – 120 |
| Control | 37 | 12 – 91 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing