Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT06193967
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2023-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Enhancing Child Dietary Self-monitoring
Sponsor:
The University of Tennessee, Knoxville
Organization:
Study Overview
Official Title:
Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial was to test the preliminary efficacy of a digital dietary self-monitoring (dDSM) log that uses positive reinforcement strategies (caregiver praise and gamification) to improve child engagement in DSM. The main aims were to:
* Conduct a proof-of-concept trial that examines the effects of positive reinforcement on child DSM behaviors.
* Explore differences in children's intrinsic motivation.
Participating children will be instructed to self-monitor their daily intake of targeted food groups (fruits, vegetables, sweet and salty snack foods, and sugar-sweetened beverages) for 4 weeks using a personal web-based DSM log. Each child-caregiver dyad will be randomly assigned to 1 of 4 conditions: BASIC, PRAISE, GAME, or PRAISE+GAME. For PRAISE and PRAISE+GAME conditions, caregivers will be instructed to provide daily process praise to their child related to DSM behaviors. For GAME and PRAISE+GAME conditions, logs will integrate three game mechanics: points, levels, and a virtual pet. Points will be accumulated for engaging in DSM behaviors, and accrual of points will evolve a virtual pet over time.
* Conduct a proof-of-concept trial that examines the effects of positive reinforcement on child DSM behaviors.
* Explore differences in children's intrinsic motivation.
Participating children will be instructed to self-monitor their daily intake of targeted food groups (fruits, vegetables, sweet and salty snack foods, and sugar-sweetened beverages) for 4 weeks using a personal web-based DSM log. Each child-caregiver dyad will be randomly assigned to 1 of 4 conditions: BASIC, PRAISE, GAME, or PRAISE+GAME. For PRAISE and PRAISE+GAME conditions, caregivers will be instructed to provide daily process praise to their child related to DSM behaviors. For GAME and PRAISE+GAME conditions, logs will integrate three game mechanics: points, levels, and a virtual pet. Points will be accumulated for engaging in DSM behaviors, and accrual of points will evolve a virtual pet over time.
Detailed Description:
The objective of the proposed study was to test the usability, acceptability, and preliminary efficacy of a digital dietary self-monitoring (dDSM) log that used positive reinforcement strategies (caregiver praise and gamification) to improve child engagement in DSM.
For this proof of concept trial, a mobile-optimized, web-based dDSM log was developed to test the two positive reinforcement strategies: caregiver praise and gamification. The dDSM log was developed as a mobile-optimized website, rather than an app, so that phone operating systems were not a limitation of use. Families were therefore able to access the dDSM log from a computer, smartphone, or other internet-enabled device. All dDSM logs included three basic features: 1) the ability to log targeted food groups with amounts and servings consumed, 2) the ability to indicate logging was complete for the day, and 3) access to a help feature that provided guidance on tracking and serving sizes. Children were instructed to self-monitor their daily intake of the following food groups: fruits, vegetables, sweet and salty snack foods, and sugar-sweetened beverages (SSBs). DSM focused on these four food groups because they had an established influence on health. Fruit and vegetable consumption was associated with a decreased risk of chronic disease, and reduced consumption of energy-dense foods like sweet and salty snacks and SSBs was recommended for weight loss in children. Additionally, these food groups were frequently targeted in childhood obesity treatment and were easily understood by young children.
Using a 2x2 factorial design, each child-caregiver dyad was randomly assigned to 1 of 4 conditions: BASIC, PRAISE, GAME, or PRAISE+GAME. Each child was provided a unique URL to access a personal dDSM log with the appropriate, randomly assigned features (praise and/or gamification). For PRAISE and PRAISE+GAME conditions, caregivers were instructed to provide daily process praise to their child related to DSM behaviors. While DSM was frequently implemented within treatment, children in the proposed study engaged in DSM without a concurrent intervention to tightly control the influence of the independent variables on DSM behaviors only (as compared to having all adult caregivers learn how to praise or having caregivers focus their praise on achieving dietary goals, which were both standard components of family-based childhood obesity interventions). Thus, only caregivers randomized to PRAISE or PRAISE+GAME were instructed on praise and, in the absence of dietary goals for intervention, caregivers had only one behavior (DSM) to praise. For GAME and PRAISE+GAME conditions, logs integrated three game mechanics: points, levels, and a virtual pet. Points were accumulated for engaging in DSM behaviors, and the accrual of points evolved a virtual pet over time, acting as a digital token economy. The number of points to level up increased with each level, so that each consecutive level was harder to attain than the previous one. At the end of the 4-week DSM period, families who completed follow-up assessments received two $25 gift cards (one for the caregiver, one for the child) and were provided access to a short online behavioral nutrition education program.
The primary DSM outcomes were frequency (i.e., the number of days any food/beverage item was tracked or logging was marked complete) and timing (i.e., how many sessions of recording were completed each day and whether foods/beverages were logged on the day of intake). On days in which no targeted food group was consumed, children had the ability to mark logging as complete for the day (Figure 1a). Indicating logging was complete in the absence of any tracked foods was considered a "tracked" day. Pre-post changes in intrinsic motivation were also examined.
For this proof of concept trial, a mobile-optimized, web-based dDSM log was developed to test the two positive reinforcement strategies: caregiver praise and gamification. The dDSM log was developed as a mobile-optimized website, rather than an app, so that phone operating systems were not a limitation of use. Families were therefore able to access the dDSM log from a computer, smartphone, or other internet-enabled device. All dDSM logs included three basic features: 1) the ability to log targeted food groups with amounts and servings consumed, 2) the ability to indicate logging was complete for the day, and 3) access to a help feature that provided guidance on tracking and serving sizes. Children were instructed to self-monitor their daily intake of the following food groups: fruits, vegetables, sweet and salty snack foods, and sugar-sweetened beverages (SSBs). DSM focused on these four food groups because they had an established influence on health. Fruit and vegetable consumption was associated with a decreased risk of chronic disease, and reduced consumption of energy-dense foods like sweet and salty snacks and SSBs was recommended for weight loss in children. Additionally, these food groups were frequently targeted in childhood obesity treatment and were easily understood by young children.
Using a 2x2 factorial design, each child-caregiver dyad was randomly assigned to 1 of 4 conditions: BASIC, PRAISE, GAME, or PRAISE+GAME. Each child was provided a unique URL to access a personal dDSM log with the appropriate, randomly assigned features (praise and/or gamification). For PRAISE and PRAISE+GAME conditions, caregivers were instructed to provide daily process praise to their child related to DSM behaviors. While DSM was frequently implemented within treatment, children in the proposed study engaged in DSM without a concurrent intervention to tightly control the influence of the independent variables on DSM behaviors only (as compared to having all adult caregivers learn how to praise or having caregivers focus their praise on achieving dietary goals, which were both standard components of family-based childhood obesity interventions). Thus, only caregivers randomized to PRAISE or PRAISE+GAME were instructed on praise and, in the absence of dietary goals for intervention, caregivers had only one behavior (DSM) to praise. For GAME and PRAISE+GAME conditions, logs integrated three game mechanics: points, levels, and a virtual pet. Points were accumulated for engaging in DSM behaviors, and the accrual of points evolved a virtual pet over time, acting as a digital token economy. The number of points to level up increased with each level, so that each consecutive level was harder to attain than the previous one. At the end of the 4-week DSM period, families who completed follow-up assessments received two $25 gift cards (one for the caregiver, one for the child) and were provided access to a short online behavioral nutrition education program.
The primary DSM outcomes were frequency (i.e., the number of days any food/beverage item was tracked or logging was marked complete) and timing (i.e., how many sessions of recording were completed each day and whether foods/beverages were logged on the day of intake). On days in which no targeted food group was consumed, children had the ability to mark logging as complete for the day (Figure 1a). Indicating logging was complete in the absence of any tracked foods was considered a "tracked" day. Pre-post changes in intrinsic motivation were also examined.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: