Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Activity Intervention for Adolescent Girls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190225
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : April 19, 2022
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Brown University
Information provided by (Responsible Party):
Britta Larsen, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Digital/social media intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 treatment: control
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Individually Tailored Physical Activity Intervention for Latina Adolescents: Chicas Fuertes
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Multi-technology physical activity intervention
Digital/social media
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)

No Intervention: Control
Control group receives a Fitbit but none of the intervention components.



Primary Outcome Measures :
  1. Objective Changes in Physical Activity (Weekly Minutes) from Baseline to 6 Months [ 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

  2. Self-Report Changes in Physical Activity (Weekly Minutes) from Baseline to 6 Months [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190225


Contacts
Layout table for location contacts
Contact: Emily D Greenstadt, MPH 858-246-5329 edgreenstadt@ucsd.edu

Locations
Layout table for location information
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Emily D Greenstadt, MPH    858-246-5329    edgreenstadt@health.ucsd.edu   
Contact: Brittany L Olesen, MPH    (858) 246-4903    bolesen@health.ucsd.edu   
Principal Investigator: Britta Larsen, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Nursing Research (NINR)
Brown University
Investigators
Layout table for investigator information
Principal Investigator: Britta Larsen, PhD UCSD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Britta Larsen, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04190225    
Other Study ID Numbers: 182070
R01NR017876 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Britta Larsen, University of California, San Diego:
physical activity
adolescents
teenagers
Latina