Clinical trial NCT05254483: Web-based Physical Activity Intervention for Children
Official title: ACTIWEB-PA (Active Children Through In-home Web-based Physical Activity): a Feasibility Trial of a Youth Targeted, Web-based Physical Activity Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity in Children
Keywords: Web based physical activity tools
Children
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 82
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Insufficient physical activity (not meeting the federal physical activity guideline of 60 min/day of moderate-to-vigorous intensity physical activity or at least 3 days per week of muscle strengthening or at least 3 days per week of bone strengthening activities as part of the daily 60 min/day of PA)
* Availability of internet in the household
* Availability of a smart-phone/computer/electronic tablet in the household
* Ability of the participant and a parent to communicate in English language

Exclusion Criteria:

* Developmental (autism), learning (dyslexia) and mental health disorders (ADHD, oppositional defiant disorder, depression, anxiety, and other mental health disorders) as diagnosed by a physician
* Parent reported disability/impairments that would interfere with the child's ability to safely perform the exercises in the videos. These include motor and sensory disabilities and impairment.

Primary outcomes:
measure: Feasibility: Percentage of Participants Recruited
timeFrame: up to 12 weeks
measure: Retention Rate: Percentage of Participants Completing 12 week Intervention
timeFrame: up to 12 weeks
measure: Adherence Rate: Percentage of Participants Performing Physical Activity (PA) on 70% of assigned Videos
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change in average number of steps per day
timeFrame: Baseline and 12 weeks (post intervention)
measure: Score on Physical functioning and psychosocial health questionnaire (PedsQL)- child reported
timeFrame: Baseline and 12 weeks (post intervention)
measure: Change in Score on Piers-Harris Children's Self-Concept Scale
timeFrame: Baseline and 12 weeks (post intervention)
Other outcomes:
measure: Change in Study Participation Experience Survey (Quantitative)
timeFrame: 6 weeks (mid intervention) and 12 weeks (post intervention)
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Lisa Cadmus-Bertram, PhD
role: PRINCIPAL_INVESTIGATOR
References: