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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child/Caregiver usability and acceptability survey

Dietary self-monitoring frequency

Dietary self-monitoring timing

Secondary study objectives

Child dietary intake

Child intrinsic motivation

Child motivation to change eating behaviors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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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