Web-based Physical Activity Intervention for Children

NCT05254483 | Completed

• 4 other identifiers: 2021-0504A176000EDUC/KINESIOLOGY/KINESIOLOGProtocol ver 4.0 04-01-2021
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity in Children

Keywords

Web based physical activity tools; Children

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  up to 12 weeks

Secondary Outcomes (3)

• Change in average number of steps per day

  Baseline and 12 weeks (post intervention)

• Score on Physical functioning and psychosocial health questionnaire (PedsQL)- child reported

  Baseline and 12 weeks (post intervention)

• Change in Score on Piers-Harris Children's Self-Concept Scale

  Baseline and 12 weeks (post intervention)

Other Outcomes (1)

• Change in Study Participation Experience Survey (Quantitative)

  6 weeks (mid intervention) and 12 weeks (post intervention)

Study Arms (2)

Intervention group (IG)

EXPERIMENTAL

Receiving exercise program immediately

Behavioral: UNICEF kid power program immediately; Device: ActiGraph Accelerometer

Waitlist Control Group (WCG)

ACTIVE COMPARATOR

Receiving exercise program after 12 week wait.

Behavioral: UNICEF kid power program for waitlist control; Device: ActiGraph Accelerometer

Interventions

UNICEF kid power program immediately BEHAVIORAL

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.

Intervention group (IG)

UNICEF kid power program for waitlist control BEHAVIORAL

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

Waitlist Control Group (WCG)

ActiGraph Accelerometer DEVICE

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.

Intervention group (IG); Waitlist Control Group (WCG)

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Study Officials

• Lisa Cadmus-Bertram, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: February 24, 2022
• Study Start: February 9, 2022
• Primary Completion: August 3, 2022
• Study Completion: September 7, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)