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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Meeting guidelines for physical activity [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Maintenance of MVPA [Срок оценки: 12 months]
• Processes of Change for Physical Activity (POC) [Срок оценки: 12 months]
• Stages of Change for Physical Activity (SCPA) [Срок оценки: 12 months]
• Self-Efficacy for Physical Activity (SE) [Срок оценки: 12 months]
• Social Support for Exercise (SSE) [Срок оценки: 12 months]
• Outcome Expectations Scale [Срок оценки: 12 months]
• Technology Engagment [Срок оценки: 12 months]
• Neighborhood Environment Walkability Scale for Youth (NEWS-Y) [Срок оценки: Baseline]
• Vital Signs [Срок оценки: 12 months]
• Perceived Stress Scale (PSS) [Срок оценки: 12 months]
• Demographics [Срок оценки: Baseline]
• Physical Activity Enjoyment Scale (PACES) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of California- San Diego — La Jolla

Публикации

• 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

Идентификаторы

NCT: NCT06595056 · 810268 · R01HL171807

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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