Clinical Trials Directory

Trials / Completed

CompletedNCT05254483

Web-based Physical Activity Intervention for Children

ACTIWEB-PA (Active Children Through In-home Web-based Physical Activity): a Feasibility Trial of a Youth Targeted, Web-based Physical Activity Intervention.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
82 (actual)
Sponsor
University of Wisconsin, Madison · Academic / Other
Sex
All
Age
8 Years – 11 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to conduct a two-arm randomized controlled trial and evaluate the feasibility, acceptability, and effects on the physical and psychosocial outcomes of children in response to a web-based physical activity intervention. 80 participants aged 8-11 will be enrolled in the Madison, WI area and can expect to be on study for up to 12 weeks.

Detailed description

The COVID-19 pandemic has facilitated the broadening of the landscape of the physical activity (PA) programs offered to children. This has been due to the fact that, traditional school-based PA offerings and other organized sport programs were on a nearly a year long hiatus. In the absence of structured PA, web-based PA programs for children garnered approval from families because of the safety and convenience offered. It is anticipated that the web-based exercise programs will remain appealing even after the pandemic is over, and may coexist with the in-person PA offerings. These programs will likely persist due to the convenience offered, the increasing penetration of 'smart' screen-based devices, and increasing usage of internet in American homes. The examples of web-based PA programs for children include, educational websites based on behavior change theories, mobile-app based PA programs, and web-based exercise videos. Of these, the latest to enter the web-based PA space and the most under-researched are the exercise videos based programs. Web-based, exercise videos feature a 'follow-after-me' format encouraging children to enact the movements shown. Examples of a few popular programs offering such videos are UNICEF Kid Power, GoNoodle, and CosmicKids Yoga. There have been no formal evaluations of web-based, exercise video programs for children so far. Moreover, there have been very few evaluations of other types of web-based PA interventions. Even fewer evaluations have addressed the impact of such programs on children's quality of life and psychosocial health. Investigators will fill this research gap by conducting a pilot trial examining the feasibility of the previously untested, exercise video based, UNICEF Kid Power intervention. Study team will also determine the effects of the program on physical and psychosocial health outcomes. Doing so will help investigators to compute the sample size of the future full-scale trial, and to optimize it based on the learnings from the pilot trial. Specific Aims Aim 1 (Primary aim): To examine the feasibility of the processes involved in implementing the UNICEF Kid Power intervention by measuring recruitment, retention, and intervention adherence rates. Aim 2: To examine the safety, acceptability, and satisfaction with the intervention using qualitative measures. Aim 3: To determine effect sizes for outcomes of physical activity, physical function, psychosocial health, and self-concept to facilitate estimation of sample size for a future full-scale randomized clinical trial.

Conditions

Interventions

TypeNameDescription
BEHAVIORALUNICEF kid power program immediatelyThe intervention will be delivered via the UNICEF Kid Power website (https://www.unicefkidpower.org/) and any screened device such as a computer, smartphone, smart TV or an electronic tablet can be used to watch the videos and perform the assigned physical activity. Participants will self-select activities 5 days a week. The participants will have the choice to undertake the physical activity in bouts and accumulate it over the course of the day. To promote adherence to intervention, a weekly email with reminder to perform the physical activity will be sent to parents. In addition, research-based articles on the importance of physical activity and behavior change in children will also be emailed.
BEHAVIORALUNICEF kid power program for waitlist controlThe wait-list control group will perform physical activity as usual and will only receive a weekly email on the importance of healthy dietary habits in children. The intervention will last 12 weeks. At the end of the study, the wait-list control group will be offered the UNICEF Kid Power intervention for a duration of 12-weeks
DEVICEActiGraph AccelerometerThe participants will be mailed accelerometers and instructed to wear for 7 consecutive days during their waking hours, prior to the start of intervention. The mail containing the accelerometer will accompany pictorial instructions, explaining in detail the correct way of wearing it.

Timeline

Start date
2022-02-09
Primary completion
2022-08-03
Completion
2022-09-07
First posted
2022-02-24
Last updated
2022-10-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05254483. Inclusion in this directory is not an endorsement.