Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial
Phase: NA
Conditions: Nutrition, Healthy
Sponsor: The University of Tennessee, Knoxville

Title: Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial 
NCT Number: NCT06193967  
Document Date: 11/07/2024 
 
 
 

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). Caregivers will be provided a separate unique URL to review their child's 
log and access the caregiver check-in feature, which will not be available in the child link. For 
PRAISE and PRAISE+GAME conditions, caregivers will be instructed to provide daily process 
praise to their child related to DSM behaviors (see additional description in the Family dDSM 
Training section below). 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 Population and Recruitment 
 

For the proof-of-concept trial, children ages 8-12 years at or above a healthy weight [defined as 
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 will be eligible for enrollment. Families will be excluded if the child is already self-
monitoring his or her diet or has major psychiatric diseases or organic brain syndromes, or if 
the family does not live in the greater Knoxville area or does not speak English. Additionally, 
families must have reliable access to the internet via phone, computer, or another device that 
the child is able and permitted to operate. 
 
Potential participants will be identified via several strategies. First, researchers will utilize the 
ongoing recruitment efforts for the Families Becoming Healthy Together (FBHT) trial (NIH 
1R01DK121360; PI: Hollie Raynor, PhD) being conducted at the Healthy Eating and Activity 
Laboratory at the University of Tennessee. FBHT is an intensive 18-month childhood 
overweight and obesity treatment program enrolling a similar population (i.e., children 8-12 
years). Given the length and intensity of the FBHT intervention, it is not a good fit for all 
families, and/or families might not meet the stringent inclusion and exclusion criteria. Families 
who screen ineligible for FBHT will be asked whether they would like to receive information 
about the proposed study. If yes, families will be referred to research staff of the proposed 
study who will provide a description of the study and complete eligibility screening by phone. 
Other recruitment strategies include recruitment flyers that will be distributed to UT 
departments via campus mail, provided to the daycare centers and other 
businesses/organizations (e.g., YMCA) for distribution to parents, distributed at community 
events (e.g., farmers markets), and posted in public spaces in the Knoxville area, and online 
advertisements will be posted on social media (e.g., Facebook) that provide a link to a 
Qualtrics form that collects contact information and obtains permission to contact. Additionally, 
researchers will set up a booth at the Cherokee Mills office campus where the University of 
Tennessee operates an office space. This campus is also occupied by a Cherokee Health 
Systems clinic that serves both adults and children who may be eligible for the proposed study. 
Finally, ResearchMatch will be used to contact a de-identified group of potential volunteers that 
might be interested.  
 
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 access to 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. 
 
Sample Size 

 
Targeted enrollment will be 40 families (10 families per group) for the proof-of-concept trial. 
 
Measures 
 
Sample characteristics   
 
Demographics. Demographic information will be used to describe the study sample. 
Information collected will include child and caregiver age, race and ethnicity, and gender and 
caregiver marital status, education level, employment status, and household income. 
 
Child height and weight. Child height and weight will be collected to confirm study eligibility, 
and BMI z-score will be calculated based on sex and age. 
 
Parenting style. Previous research has associated parenting style with intrinsic motivation in 
children. To determine parenting style, caregivers will complete Parenting Styles and 
Dimensions Questionnaire (PSDQ)-Short Version. The PDSQ-Short Version is a 32-item 
questionnaire that uses a 5-point Likert scale (never to always) to provide scores for three 
parenting style factors: authoritativeness, authoritarianism, and permissiveness. 
 
Primary measures: DSM behaviors 
 
Foods, beverages, and serving sizes entered in the dDSM logs by participants will 
automatically populate a web-based spreadsheet that will collect participant ID number, date 
and time of entry, food/beverage name, and serving size. This spreadsheet will be exported to 
Microsoft Excel, and data management and analysis will be conducted in SAS Enterprise 
Guide 8.3. 
 
Frequency. I.e., number of days with any logging. DSM frequency has been shown to predict 
success in family-based based childhood overweight and obesity programs. A day will be 
counted as “tracked” if any food or beverage is logged on that day or, if no food or beverage is 
logged, the “Logging Complete” button is clicked. 
 
Timing. I.e., proportion of days on which food/beverage items were tracked on the day of 
intake, as well as the average number of logging sessions per day. Sessions will be considered 
as distinct tracking events if they occur >15 minutes apart. 
 
Secondary measures 
 
Child intrinsic motivation. Gamification and caregiver praise may differentially affect child 
motivation to engage in DSM. The Task Evaluation Questionnaire of the Intrinsic Motivation 
Inventory (IMI) will be used to determine whether are differences in pre-post changes in child 
intrinsic motivation. This questionnaire consists of 22 items and utilizes a 5-point Likert scale 
(not at all true to very true) to assess interest/enjoyment, perceived choice, perceived 
competence, and pressure/tension. At baseline, the measure will be administered after the 
child has practiced using dDSM with the research assistant so that he or she has some 
familiarity with the behavior before completing the measure. 
 
Child motivation to change eating behaviors. Child’s motivation to change eating habits will be 
measured, as this may influence engagement in DSM. Children will be asked to complete the 

8-item diet subscale of the Motivation to Exercise and Diet Questionnaire—Adapted for 
Children (MED-C), which is based on self-determination theory. The MED-C diet subscale 
utilizes a 5-point Likert scale (never to always) and includes 5 items related to motivation and 3 
items related to self-determination theory needs (autonomy, competence, relatedness). This 
validity of the questionnaire has been tested in children aged 7 to 11 years. 
 
Child dietary intake. The act of self-monitoring a behavior may result in reactivity, or 
improvements in the monitored behavior in the absence of other intervention. Thus, child 
dietary intake will also be assessed at baseline and follow-up using the Block Food Screener 
for Ages 2-17 2007. The instrument asks about intake in the “last week” and focuses on take of 
fruit, fruit juices, vegetables, potatoes (including French fries), whole grains, animal-based 
proteins, dairy, legumes, saturated fat, added sugars (in sweetened cereals, SSBs), glycemic 
load and glycemic index. It takes approximately 10-12 minutes to complete. 
 
Usability and acceptability  
 
Child/Caregiver usability and acceptability survey. A survey will be developed (adapted from 
Marsac et al.108) to capture family’s experiences with the dDSM log, as well as the caregiver 
praise (PRAISE and PRAISE+GAME only) and gamification (GAME and PRAISE+GAME only) 
features. The survey will address both usability and acceptability. 
 
Adherence and dose 
 
Caregiver praise. To examine whether the caregiver praise manipulation was successfully 
implemented, the number of completed caregiver check-ins in which the caregiver marked ‘yes’ 
for praise provided will be calculated. 
 
Caregiver reminder questionnaires. To examine whether caregivers avoided the use of 
negative reinforcement (e.g., nagging), items related to caregiver reminders will be 
administered to the child and parent at follow up. 
 
Gamification. To examine whether the gamification manipulation was successfully 
implemented, the average number of points received/levels achieved will be calculated. Higher 
point totals and maximum levels will indicate receipt of a higher dose of the gamification 
manipulation. 
 
Statistical Analysis 
 
Summary statistics will be used to describe sample characteristics (demographics, child weight 
status, parenting style). Intent-to-treat analysis will be performed, and missing data will be 
addressed using a multiple imputation approach. Absence/presence of DSM will be coded as 
‘0’ or ‘1’ for each day, with ‘0’ representing no food or beverage tracked AND tracking not 
marked as complete for the day and ‘1’ representing ≥1 food or beverage tracked AND/OR 
tracking marked as complete for the day. Therefore, the possible range for overall DSM 
frequency for the 4-week period will range from 0 (no DSM any day) to 28 (DSM on all days). 
The possible range for DSM by week will range from 0 to 7. DSM timing will be calculated two 
ways: 1) the mean number of DSM sessions per day (must be >15 minutes apart to be 
considered distinct sessions) and 2) the percent of food or beverage items tracked on the day 
of intake (i.e., the number of food or beverage items tracked on the day of intake divided by the 
total number of food or beverage items tracked). To assess dose of positive reinforcement 

received, the mean number of points accumulated by children in the GAME groups will be 
calculated, as well as the total number of days in which praise check-ins were completed for 
children in the PRAISE groups. 
 
To determine the main effects of positive reinforcement on DSM behavior, a 2x2 factorial 
ANOVA will be conducted with gamification and caregiver praise status as the independent 
variables and a dependent variable of DSM behavior (frequency or timing). A 
gamification*caregiver praise interaction term will also be included in the model to test for 
interactive effects. 
 
To examine how DSM changes over time, linear mixed-factor ANOVA will be used with a 
between-subject factor of group, a within-subject factor of time (week), and a dependent 
variable of DSM behavior (frequency or timing). Additionally, graphical representations of daily 
DSM frequency and timing by group will be plotted to help visualize trends over time. 
 
To explore how positive reinforcement influences motivation, a 2x2 factorial ANCOVA will be 
conducted with gamification and caregiver praise status as the independent variables, a 
dependent variable of intrinsic motivation at follow-up, and a covariate of intrinsic motivation at 
baseline. A gamification*caregiver praise interaction term will also be included in the model to 
test for interactive effects. This statistical procedure will be repeated with the other secondary 
measures of child motivation to change eating behaviors and child dietary intake, with follow-up 
measures as the dependent variable and baseline measures as covariate. 
 
To examine how changes in secondary measures over time, linear mixed-factor ANOVA will be 
used with a between-subject factor of group, a within-subject factor of time (baseline and 
follow-up), and a dependent variable of intrinsic motivation, child motivation to change eating 
behaviors, or child dietary intake, respectively.