Physical Activity Intervention for Adolescent Girls

NCT04190225 | Completed Results

• 2 other identifiers: 182070R01NR017876
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity

Keywords

physical activity; adolescents; teenagers; Latina

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline, 6 Months (MO)

Secondary Outcomes (1)

• Objectively Measured Weekly Minutes Minutes of Activity

  12 months

Study Arms (2)

Multi-technology physical activity intervention

EXPERIMENTAL

Digital/social media

Behavioral: Digital/social media intervention

Control

NO INTERVENTION

Control group receives a Fitbit but none of the intervention components.

Interventions

Digital/social media intervention BEHAVIORAL

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)

Multi-technology physical activity intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• self identify as Latina
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Nursing Research (NINR): collaborator
• Brown University: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Larsen 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.

  PMID: 35197106 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Shira Dunsiger, Biostatistician
• Organization: Brown University

shira_dunsiger@brown.edu

401-863-6747

Study Officials

• Britta Larsen, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 1:1 treatment: control

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 9, 2019
• Study Start: August 6, 2020
• Primary Completion: November 21, 2023
• Study Completion: May 24, 2024
• Last Updated: December 9, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)