Clinical trial NCT06193967: Enhancing Child Dietary Self-monitoring
Official title: Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 factorial design
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to test the usability, acceptability, and 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 are to:

* Examine the usability of a dDSM log that uses positive reinforcement (praise and gamification) among children 8-12 years and their adult caregivers.
* Examine the acceptability of a dDSM log that uses positive reinforcement (praise and gamification) among children 8-12 years and their adult caregivers
* 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 is to test the usability, acceptability, and 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.

For this proof of concept trial, a mobile-optimized, web-based dDSM log will be developed to test the two positive reinforcement strategies: caregiver praise and gamification. The dDSM log will be developed as a mobile-optimized website, rather than an app, so that phone operating system will not be a limitation of use. Families will therefore be able to access the dDSM log from a computer, smartphone, or other internet-enabled device. All dDSM logs will include three basic features: 1) ability to log targeted food groups with amounts and serving consumed, 2) ability to indicate logging is complete for the day, and 3) access to a help feature that provides guidance on tracking and serving sizes. Children will be 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 will focus on these four food groups because they have an established influence on health. Fruit and vegetable consumption is associated with decreased risk of chronic disease, and reduced consumption of energy-dense foods like sweet and salty snacks and SSBs is recommended for weight loss in children. Additionally, these food groups are frequently targeted in childhood obesity treatment and are easily understood by young children.

Using a 2x2 factorial design, each child-caregiver dyad will be randomly assigned to 1 of 4 conditions: BASIC, PRAISE, GAME, or PRAISE+GAME. Each child will be 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 will be instructed to provide daily process praise to their child related to DSM behaviors. While DSM is frequently implemented within treatment, children in the proposed study will engage 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 learning how to praise or having caregivers focus their praise on achieving dietary goals, which are both standard components of family-based, childhood obesity interventions). Thus, only caregivers randomized to PRAISE or PRAISE+GAME will be instructed on praise and, in the absence of dietary goals for intervention, caregivers will only have one behavior (DSM) to praise. 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, acting as digital token economy. The number of points to level up will increase with each level, so that each consecutive level is harder to attain than the previous one. At the end of the 4-week DSM period, families who complete follow-up assessments will receive two $25 gift cards (one for caregiver, one for child) and will be provided access to a short online behavioral nutrition education program.

The primary DSM outcomes will be frequency (i.e., number of days any food/beverage item is tracked or logging is marked complete) and timing (i.e., how many sessions of recording are completed each day and whether foods/beverages were logged on the day of intake). On days in which no targeted food group is consumed, children will have the ability to mark logging as complete for the day (Figure 1a). Indicating logging is complete in the absence of any tracked foods will be considered a "tracked" day. Pre-post changes in intrinsic motivation will also be examined.

Study Flow

After an initial phone screening to determine eligibility, interested families will be invited to attend an orientation at the Healthy Eating and Activity Laboratory (HEAL) at the University of Tennessee Knoxville. For families who agree to participate, caregivers will complete informed consent forms and children will provide assent. After consent/assent, families will complete baseline assessment measures (see Measures). Immediately after baseline measures are completed, families will be told their assigned condition (randomized using a random numbers table). All families will be provided information on the benefits of DSM and the relationships of the four targeted food groups with child health. Families will be informed that the child's DSM records over the next 4 weeks will be used to provide individualized feedback on their child's nutrition status at their follow-up visit, at which time they will receive access to a short online behavioral nutrition education program (described below).

Each family will be provided a personal URL for a dDSM log that matches group assignment. Caregivers will be instructed to review their child's DSM each day and complete a caregiver check in. Additionally, to get children started, all caregivers will be instructed to sit with their child each day for the first 3 days of the DSM period to help their child log any foods consumed from targeted food groups. If no logging is completed within the first 4 days of a family's DSM period, a research assistant will reach out to the caregiver to problem solve and provide support.

At the end of the 4-week DSM period, families will schedule a virtual appointment to complete follow-up assessment measures. To provide feedback to families, days for which tracking was marked as completed in the dDSM log will be entered into the Nutrition Data System for Research (NDSR) software to determine servings of fruits and vegetables consumed, as well as intake of added sugars and saturated fats from sugar-sweetened beverages and sweet and salty snack foods. These values will be entered into a feedback template that compares the child's intake to the recommendations in the Dietary Guidelines for Americans (DGA) 2020-2025. Families will also be provided access to a short online behavioral nutrition education program that will consist of four modules: 1) DGA recommendations and basic nutrition information, 2) establishing a healthy home environment, 3) positive reinforcement of healthy behaviors, and 4) pre-planning and problem solving.

Family dDSM Training. After baseline measures, families will complete a DSM practice session using their dDSM log under the observation of research staff. The family's personal dDSM will be used; therefore, GAME/PRAISE features related to the family's assigned condition will be included. The family will practice logging foods and beverages from a standard list and will then be instructed to mark logging as complete for the day. Research staff will answer any questions the family has and will explain how to use the "Help Me Log" feature. Caregivers will also be shown how to complete the caregiver check in feature.

For families randomized to the PRAISE conditions (PRAISE and PRAISE+GAME), caregivers will also provide praise to their child during the DSM practice session so that research staff can observe and provide feedback. During training session, caregivers will be provided a brief training on providing process praise. A description of process praise will be provided, including a list of examples, and caregivers will complete a brief "quiz" in which they attempt to correctly identify process praise statements. Caregivers will also be encouraged to avoid negative reinforcement (e.g., nagging). If the caregiver notices the child is not using the dDSM log, he or she will be encouraged to engage in problem solving/preplanning (rather than nagging) to encourage the child to self-monitor. If the caregiver notices the child is engaging in undesirable behaviors (e.g., recording unhealthy foods), this should be ignored rather than criticized. Additionally, caregivers will be encouraged to provide the praise as close to the occurrence of the behavior as possible to increase its effectiveness. For PRAISE conditions, completion of the caregiver check-in will prompt the caregiver to also complete a praise check-in ("Would you also like to complete a praise check in?"). If no praise check-ins are completed within the first 4 days of the DSM period, a research assistant will reach out to the caregiver to problem solve and provide support.

For families randomized to GAME conditions (GAME and PRAISE+GAME), children and caregivers will observe how points are accrued during the DSM practice session. Prior to the practice session, research staff will explain how points are earned and how points help to "level up" the virtual pet. Points will be accrued and represented in the dDSM log in real time so that children will immediately be rewarded for engaging is DSM behaviors.

At the conclusion of the study, results will be disseminated to former participants via email.

Eligibility criteria: Inclusion Criteria:

* Families with children ages 8-12 years with body mass index (BMI)-for-age ≥ 5th percentile who report eating foods/beverages (any serving size) from ≥2 targeted food groups (fruits, vegetables, sweet and salty snack foods, and SSBs) on ≥3 days/week each and who have an adult caregiver ≥18 years of age willing to participate
* Family has reliable access to the internet via phone, computer, or another device that the child is able and permitted to operate

Exclusion Criteria:

* Child has major psychiatric diseases or organic brain syndromes
* Family does not live in the greater Knoxville area
* Family does not speak English

Primary outcomes:
measure: Dietary self-monitoring frequency
timeFrame: 4 weeks
measure: Dietary self-monitoring timing
timeFrame: 4 weeks
measure: Child/Caregiver usability and acceptability survey
timeFrame: 4 weeks
Secondary outcomes:
measure: Child intrinsic motivation
timeFrame: 4 weeks
measure: Child motivation to change eating behaviors
timeFrame: 4 weeks
measure: Child dietary intake
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
Study officials:
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