Nutrition, HealthyNCT06193967
Enhancing Child Dietary Self-monitoring
A study testing Caregiver Praise and Gamification in people with Nutrition, Healthy, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Caregiver Praise and Gamification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Child has major psychiatric diseases or organic brain syndromes
- Family does not live in the greater Knoxville area
- Family does not speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial
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.
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- Caregiver Praise, Gamification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver PraiseBehavioural
Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement
GamificationBehavioural
DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors
| Study group | Role | What they receive |
|---|---|---|
| BASIC | No 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. |
| PRAISE | Experimental | 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. Receives: Behavioral: Caregiver Praise |
| GAME | Experimental | 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. Receives: Behavioral: Gamification |
| PRAISE+GAME | Experimental | 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. Receives: Behavioral: Caregiver Praise; Behavioral: Gamification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Self-monitoring Frequency, Overall
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.
Measured: 4 weeks
Dietary Self-monitoring Frequency, Weekly
I.e., number of days with any logging per week
Measured: 4 weeks
Proportion of Items Tracked on Day of Intake, Overall
Proportion of food/beverage items that were tracked on the day of intake across the 4-week DSM period
Measured: 4 weeks
Proportion of Items Tracked on Day of Intake, Weekly
Proportion of food/beverage items that were tracked on the day of intake by week
Measured: 4 weeks
Number of Logging Sessions, Overall
The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred >15 minutes apart.
Measured: 4 weeks
Number of Logging Sessions, Weekly
The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred >15 minutes apart.
Measured: 4 weeks
Secondary outcomes (7)
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) was used to determine whether there were 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 was administered after the child has practiced using the log with the research assistant so that he or she had some familiarity with the behavior before completing the measure.
Scales range from 1 to 7, with a higher score indicating a greater degree of the respective motivation subdomain.
Measured: 4 weeks
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.
Scale ranges from 0 to 32, with a higher score indicating greater motivation to change eating habits.
Measured: 4 weeks
Child Dietary Intake, Fruit
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, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.
Measured: 4 weeks
Child Dietary Intake, Vegetables Excluding Potatoes
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, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.
Measured: 4 weeks
Child Dietary Intake, Potatoes
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, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.
Measured: 4 weeks
Child Dietary Intake, Sweet & Salty Snack Foods
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, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.
Measured: 4 weeks
Child Dietary Intake, Sugar-sweetened Beverages
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, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start4 Apr 2024
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 factorial design
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193967
- Sponsor's protocol ID
- UTK IRB-23-07903-XP
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2023
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Germann JN, Kirschenbaum DS, Rich BH. Child and parental self-monitoring as determinants of success in the treatment of morbid obesity in low-income minority children. J Pediatr Psychol. 2007 Jan-Feb;32(1):111-21. doi: 10.1093/jpepsy/jsl007. Epub 2006 Jun 14.
PubMed 16775083Mockus DS, Macera CA, Wingard DL, Peddecord M, Thomas RG, Wilfley DE. Dietary self-monitoring and its impact on weight loss in overweight children. Int J Pediatr Obes. 2011 Aug;6(3-4):197-205. doi: 10.3109/17477166.2011.590196. Epub 2011 Jul 4.
PubMed 21722068Saelens BE, McGrath AM. Self-monitoring adherence and adolescent weight control efficacy. Children's Health Care. 2003;32(2):137-152.
Dalle Grave R, Centis E, Marzocchi R, El Ghoch M, Marchesini G. Major factors for facilitating change in behavioral strategies to reduce obesity. Psychol Res Behav Manag. 2013 Oct 3;6:101-10. doi: 10.2147/PRBM.S40460.
PubMed 24124398Guideline Development Panel for Treatment of Obesity, American Psychological Association. Summary of the clinical practice guideline for multicomponent behavioral treatment of obesity and overweight in children and adolescents. Am Psychol. 2020 Feb-Mar;75(2):178-188. doi: 10.1037/amp0000530.
PubMed 32052993Favell JE. The power of positive reinforcement: a handbook of behavior modification. Charles C Thomas; 1977.
Griffiths LA, Douglas SM, Raynor HA. The role of structure in dietary approaches for the treatment of pediatric overweight and obesity: A critical review. Obes Rev. 2021 Sep;22(9):e13266. doi: 10.1111/obr.13266. Epub 2021 May 5.
PubMed 33955110Henggeler SW, Sheidow AJ. Empirically supported family-based treatments for conduct disorder and delinquency in adolescents. J Marital Fam Ther. 2012 Jan;38(1):30-58. doi: 10.1111/j.1752-0606.2011.00244.x. Epub 2011 Sep 20.
PubMed 22283380Freeman JB, Garcia AM. Family based treatment for young children with OCD: therapist guide. Oxford University Press; 2008.
Garett R, Young SD. Health care gamification: a study of game mechanics and elements. Technology, Knowledge and Learning. 2019;24(3):341-353.
Kumar VS, Wentzell KJ, Mikkelsen T, Pentland A, Laffel LM. The DAILY (Daily Automated Intensive Log for Youth) trial: a wireless, portable system to improve adherence and glycemic control in youth with diabetes. Diabetes Technol Ther. 2004 Aug;6(4):445-53. doi: 10.1089/1520915041705893.
PubMed 15320998Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058.
PubMed 22564332Klingensmith GJ, Aisenberg J, Kaufman F, Halvorson M, Cruz E, Riordan ME, Varma C, Pardo S, Viggiani MT, Wallace JF, Schachner HC, Bailey T. Evaluation of a combined blood glucose monitoring and gaming system (Didget(R)) for motivation in children, adolescents, and young adults with type 1 diabetes. Pediatr Diabetes. 2013 Aug;14(5):350-7. doi: 10.1111/j.1399-5448.2011.00791.x. Epub 2011 Jun 23.
PubMed 21699639Swartwout E, El-Zein A, Deyo P, Sweenie R, Streisand R. Use of Gaming in Self-Management of Diabetes in Teens. Curr Diab Rep. 2016 Jul;16(7):59. doi: 10.1007/s11892-016-0754-2.
PubMed 27155609Debong F, Mayer H, Kober J. Real-World Assessments of mySugr Mobile Health App. Diabetes Technol Ther. 2019 Jun;21(S2):S235-S240. doi: 10.1089/dia.2019.0019.
PubMed 31169427
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial
- ClinicalTrials.gov ID
- NCT06193967
- Acronym / sponsor ID
- UTK IRB-23-07903-XP
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 3 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 x 2 factorial design
| Arm | Type | Receives |
|---|---|---|
| BASIC | No 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. |
| PRAISE | Experimental | Behavioral: Caregiver PraiseIn 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. |
| GAME | Experimental | Behavioral: GamificationIn 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. |
| PRAISE+GAME | Experimental | Behavioral: Caregiver Praise, Behavioral: GamificationIn 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. |
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Child has major psychiatric diseases or organic brain syndromes
- Family does not live in the greater Knoxville area
- Family does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver PraiseCaregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement | Behavioural | PRAISE, PRAISE+GAME |
| GamificationDSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors | Behavioural | GAME, PRAISE+GAME |
Primary outcome
Dietary Self-monitoring Frequency, Overall
Time frame: 4 weeks
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.
Dietary Self-monitoring Frequency, Weekly
Time frame: 4 weeks
I.e., number of days with any logging per week
Proportion of Items Tracked on Day of Intake, Overall
Time frame: 4 weeks
Proportion of food/beverage items that were tracked on the day of intake across the 4-week DSM period
Proportion of Items Tracked on Day of Intake, Weekly
Time frame: 4 weeks
Proportion of food/beverage items that were tracked on the day of intake by week
Number of Logging Sessions, Overall
Time frame: 4 weeks
The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred >15 minutes apart.
Number of Logging Sessions, Weekly
Time frame: 4 weeks
The average number of logging sessions per day. Sessions were considered distinct tracking events if they occurred >15 minutes apart.
7 secondary outcomes
Child Intrinsic Motivation
Time frame: 4 weeks
Child Motivation to Change Eating Behaviors
Time frame: 4 weeks
Child Dietary Intake, Fruit
Time frame: 4 weeks
Child Dietary Intake, Vegetables Excluding Potatoes
Time frame: 4 weeks
Child Dietary Intake, Potatoes
Time frame: 4 weeks
Child Dietary Intake, Sweet & Salty Snack Foods
Time frame: 4 weeks
Child Dietary Intake, Sugar-sweetened Beverages
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16775083Germann JN, Kirschenbaum DS, Rich BH. Child and parental self-monitoring as determinants of success in the treatment of morbid obesity in low-income minority children. J Pediatr Psychol. 2007 Jan-Feb;32(1):111-21. doi: 10.1093/jpepsy/jsl007. Epub 2006 Jun 14.
- Background: PubMed 21722068Mockus DS, Macera CA, Wingard DL, Peddecord M, Thomas RG, Wilfley DE. Dietary self-monitoring and its impact on weight loss in overweight children. Int J Pediatr Obes. 2011 Aug;6(3-4):197-205. doi: 10.3109/17477166.2011.590196. Epub 2011 Jul 4.
- BackgroundSaelens BE, McGrath AM. Self-monitoring adherence and adolescent weight control efficacy. Children's Health Care. 2003;32(2):137-152.
- Background: PubMed 24124398Dalle Grave R, Centis E, Marzocchi R, El Ghoch M, Marchesini G. Major factors for facilitating change in behavioral strategies to reduce obesity. Psychol Res Behav Manag. 2013 Oct 3;6:101-10. doi: 10.2147/PRBM.S40460.
- Background: PubMed 32052993Guideline Development Panel for Treatment of Obesity, American Psychological Association. Summary of the clinical practice guideline for multicomponent behavioral treatment of obesity and overweight in children and adolescents. Am Psychol. 2020 Feb-Mar;75(2):178-188. doi: 10.1037/amp0000530.
- BackgroundFavell JE. The power of positive reinforcement: a handbook of behavior modification. Charles C Thomas; 1977.
- Background: PubMed 33955110Griffiths LA, Douglas SM, Raynor HA. The role of structure in dietary approaches for the treatment of pediatric overweight and obesity: A critical review. Obes Rev. 2021 Sep;22(9):e13266. doi: 10.1111/obr.13266. Epub 2021 May 5.
- Background: PubMed 22283380Henggeler SW, Sheidow AJ. Empirically supported family-based treatments for conduct disorder and delinquency in adolescents. J Marital Fam Ther. 2012 Jan;38(1):30-58. doi: 10.1111/j.1752-0606.2011.00244.x. Epub 2011 Sep 20.
- BackgroundFreeman JB, Garcia AM. Family based treatment for young children with OCD: therapist guide. Oxford University Press; 2008.
- BackgroundGarett R, Young SD. Health care gamification: a study of game mechanics and elements. Technology, Knowledge and Learning. 2019;24(3):341-353.
- Background: PubMed 15320998Kumar VS, Wentzell KJ, Mikkelsen T, Pentland A, Laffel LM. The DAILY (Daily Automated Intensive Log for Youth) trial: a wireless, portable system to improve adherence and glycemic control in youth with diabetes. Diabetes Technol Ther. 2004 Aug;6(4):445-53. doi: 10.1089/1520915041705893.
- Background: PubMed 22564332Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Praise and Gamification in people with Nutrition, Healthy, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Self-monitoring Frequency, Overall (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06193967, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.