Physical Activity Intervention for Adolescent Girls

Physical Activity Clinical Trial

Official title:

Individually Tailored Physical Activity Intervention for Latina Adolescents: Chicas Fuertes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04190225
• Other study ID #: 182070
• Secondary ID: R01NR017876
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: July 1, 2024
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Digital/social media intervention
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)

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Brown University, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Changes in Physical Activity (Weekly Minutes) from Baseline to 6 Months	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	Baseline, 6 Months (MO)
Primary	Self-Report Changes in Physical Activity (Weekly Minutes) from Baseline to 6 Months	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.	Baseline, 6 Months (MO)