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Behavioural Intervention
Caregiver Praise + Gamification for Healthy Nutrition
N/A
Recruiting
Research Sponsored by The University of Tennessee, Knoxville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Summary
This trial aims to test a digital dietary self-monitoring log that uses positive reinforcement strategies to encourage children aged 8-12 and their caregivers to engage in dietary self-monitoring. The study will assess
Who is the study for?
This trial is for families with children aged 8-12 who are overweight or obese and regularly consume foods from at least two of the following groups: fruits, vegetables, sweet/salty snacks, and sugary drinks. They must have reliable internet access and an adult caregiver willing to participate.
What is being tested?
The study tests a digital dietary self-monitoring log that encourages kids to track their food intake using praise from caregivers and game-like features. Children will be randomly placed in one of four groups to see which method boosts engagement in healthy eating habits.
What are the potential side effects?
There are no medical side effects expected as this trial involves behavioral interventions like caregiver praise and gamification rather than medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child/Caregiver usability and acceptability survey
Dietary self-monitoring frequency
Dietary self-monitoring timing
Secondary outcome measures
Child dietary intake
Child intrinsic motivation
Child motivation to change eating behaviors
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: PRAISE+GAMEExperimental Treatment2 Interventions
In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in. The child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.
Group II: PRAISEExperimental Treatment1 Intervention
In addition to conditions of the BASIC group, caregivers will also be asked to provide praise to their child for engaging in DSM over the 4 weeks. Additionally, when the caregiver completes caregiver check-ins in the DSM log, they will receive a prompt to also complete a praise check-in.
Group III: GAMEExperimental Treatment1 Intervention
In addition to the conditions of the BASIC group, the child's log will also include a virtual pet that evolves over time as he/she uses the log. As the child earns points, the pet will level up and grow over time.
Group IV: BASICActive Control1 Intervention
Children will be asked to track their intake of fruits, vegetables, sweet and salty snack foods, and sugary drinks in the web-based dietary self-monitoring (DSM) log for 4 weeks. Each child will be provided with a personal URL to access their log, which can be accessed from any internet-capable device (computer, phone, etc.). Caregivers will be asked to review their child's log each day and complete a caregiver check-in in the DSM log.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gamification
2019
Completed Phase 3
~3090
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Who is running the clinical trial?
The University of Tennessee, KnoxvilleLead Sponsor
85 Previous Clinical Trials
18,662 Total Patients Enrolled
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