Physical Activity in ChildrenNCT05254483
Web-based Physical Activity Intervention for Children
A study testing UNICEF kid power program immediately and ActiGraph Accelerometer in people with Physical Activity in Children, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity in Children
- What is being tested?
- UNICEF kid power program immediately and ActiGraph Accelerometer
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 7 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Physical Activity in Children
- Being tested
- UNICEF kid power program immediately, UNICEF kid power program for waitlist control, ActiGraph Accelerometer
- Keywords
- Web based physical activity tools, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNICEF kid power program immediatelyBehavioural
The 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.
UNICEF kid power program for waitlist controlBehavioural
The 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
ActiGraph AccelerometerDevice
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (IG) | Experimental | Receiving exercise program immediately Receives: Behavioral: UNICEF kid power program immediately; Device: ActiGraph Accelerometer |
| Waitlist Control Group (WCG) | Active comparator | Receiving exercise program after 12 week wait. Receives: Behavioral: UNICEF kid power program for waitlist control; Device: ActiGraph Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Percentage of Participants Recruited
Proportion of recruited will be computed by dividing the number of participants recruited into the study by those who completed the screener and met the eligibility criteria. This proportion will then be converted into a percentage. A priori target of 50% recruitment rate will be set.
Measured: up to 12 weeks
Retention Rate: Percentage of Participants Completing 12 week Intervention
Retention rate will be computed as the percentage of randomized participants completing 12-week assessments. A priori target of 80% retention rate will be set.
Measured: up to 12 weeks
Adherence Rate: Percentage of Participants Performing Physical Activity (PA) on 70% of assigned Videos
Adherence to intervention will be monitored as a measure of implementation fidelity. This will be expressed as the percentage of participants performing PA on 70% of the assigned videos each week of the intervention period.
Measured: up to 12 weeks
Secondary outcomes (3)
Change in average number of steps per day
Physical activity will be assessed by measuring average step counts per day by pedometer at baseline and 12-weeks. Parents will be reporting children's step-count in an online log at the end of every day.
Measured: Baseline and 12 weeks (post intervention)
Score on Physical functioning and psychosocial health questionnaire (PedsQL)- child reported
PedsQL assesses four dimensions of health: physical functioning, social functioning, emotional functioning, and school functioning. The latter three dimensions can also be aggregated to create a "psychosocial health summary score." The scale is an ideal choice because it addresses a broad range of psychosocial domains including emotional aspects related to symptoms of anxiety and sadness. Because PedsQL scale is designed to be interviewer-administered, it will be completed by the children during a videocall with the study coordinator.
It is a 23 item scale. Each item can be answered on a scale of "0-4" where 0 - never a problem, 1 - Almost never a problem, 2- Sometimes a problem, 3 - Often a problem, 4 - Almost always a problem. Higher scores indicate worse physical and psychological health.
Measured: Baseline and 12 weeks (post intervention)
Change in Score on Piers-Harris Children's Self-Concept Scale
Piers-Harris Children's Self-Concept Scale (3rd ed) assesses self-concept and comprises 58 items and six domains. Children/adolescents indicate whether each item applies to them by selecting a yes or no response. Raw scores are converted to standardized T-scores. Higher scores indicate favorable self-concept whereas lower scores mean lower self-concept in both global and domain-specific scales.
Measured: Baseline and 12 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start9 Feb 2022
- Primary completion3 Aug 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Activity in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Cadmus-Bertram, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254483
- Sponsor's protocol ID
- 2021-0504
- Other IDs
- A176000, EDUC/KINESIOLOGY/KINESIOLOG, Protocol ver 4.0 04-01-2021
- Status last verified
- Oct 2022
- First submitted
- 23 Feb 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05254483
- Acronym / sponsor ID
- 2021-0504
- Conditions
- Physical Activity in Children
- Keywords
- Web based physical activity tools, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG) | Experimental | Behavioral: UNICEF kid power program immediately, Device: ActiGraph AccelerometerReceiving exercise program immediately |
| Waitlist Control Group (WCG) | Active comparator | Behavioral: UNICEF kid power program for waitlist control, Device: ActiGraph AccelerometerReceiving exercise program after 12 week wait. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNICEF 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. | Behavioural | Intervention group (IG) |
| UNICEF 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 | Behavioural | Waitlist Control Group (WCG) |
| ActiGraph 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. | Device | Intervention group (IG), Waitlist Control Group (WCG) |
Primary outcome
Feasibility: Percentage of Participants Recruited
Time frame: up to 12 weeks
Proportion of recruited will be computed by dividing the number of participants recruited into the study by those who completed the screener and met the eligibility criteria. This proportion will then be converted into a percentage. A priori target of 50% recruitment rate will be set.
Retention Rate: Percentage of Participants Completing 12 week Intervention
Time frame: up to 12 weeks
Retention rate will be computed as the percentage of randomized participants completing 12-week assessments. A priori target of 80% retention rate will be set.
Adherence Rate: Percentage of Participants Performing Physical Activity (PA) on 70% of assigned Videos
Time frame: up to 12 weeks
Adherence to intervention will be monitored as a measure of implementation fidelity. This will be expressed as the percentage of participants performing PA on 70% of the assigned videos each week of the intervention period.
3 secondary outcomes
Change in average number of steps per day
Time frame: Baseline and 12 weeks (post intervention)
Score on Physical functioning and psychosocial health questionnaire (PedsQL)- child reported
Time frame: Baseline and 12 weeks (post intervention)
Change in Score on Piers-Harris Children's Self-Concept Scale
Time frame: Baseline and 12 weeks (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Cadmus-Bertram, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNICEF kid power program immediately and ActiGraph Accelerometer in people with Physical Activity in Children, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Percentage of Participants Recruited (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.