NCT06193967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 3, 2025

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

December 21, 2023

Results QC Date

April 1, 2025

Last Update Submit

December 1, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    4 weeks

  • Dietary Self-monitoring Frequency, Weekly

    I.e., number of days with any logging per week

    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

    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

    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.

    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.

    4 weeks

Secondary Outcomes (7)

  • Child Intrinsic Motivation

    4 weeks

  • Child Motivation to Change Eating Behaviors

    4 weeks

  • Child Dietary Intake, Fruit

    4 weeks

  • Child Dietary Intake, Vegetables Excluding Potatoes

    4 weeks

  • Child Dietary Intake, Potatoes

    4 weeks

  • +2 more secondary outcomes

Study Arms (4)

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.

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.

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.

Behavioral: Caregiver PraiseBehavioral: Gamification

Interventions

Caregivers will provide praise for child's engagement in dietary self-monitoring behaviors as a form of positive reinforcement

PRAISEPRAISE+GAME
GamificationBEHAVIORAL

DSM logs will include gamification (points, levels, virtual pets) as positive reinforcement for child's engagement in dietary self-monitoring behaviors

GAMEPRAISE+GAME

Eligibility Criteria

Age8 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (18)

  • 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.

    PMID: 16775083BACKGROUND
  • Mockus 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.

    PMID: 21722068BACKGROUND
  • Saelens BE, McGrath AM. Self-monitoring adherence and adolescent weight control efficacy. Children's Health Care. 2003;32(2):137-152.

    BACKGROUND
  • 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.

    PMID: 24124398BACKGROUND
  • Guideline 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.

    PMID: 32052993BACKGROUND
  • Favell JE. The power of positive reinforcement: a handbook of behavior modification. Charles C Thomas; 1977.

    BACKGROUND
  • 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.

    PMID: 33955110BACKGROUND
  • Henggeler 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.

    PMID: 22283380BACKGROUND
  • Freeman JB, Garcia AM. Family based treatment for young children with OCD: therapist guide. Oxford University Press; 2008.

    BACKGROUND
  • Garett R, Young SD. Health care gamification: a study of game mechanics and elements. Technology, Knowledge and Learning. 2019;24(3):341-353.

    BACKGROUND
  • 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.

    PMID: 15320998BACKGROUND
  • Cafazzo 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.

    PMID: 22564332BACKGROUND
  • Klingensmith 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.

    PMID: 21699639BACKGROUND
  • Swartwout 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.

    PMID: 27155609BACKGROUND
  • Debong 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.

    PMID: 31169427BACKGROUND
  • Deci EL, Koestner R, Ryan RM. A meta-analytic review of experiments examining the effects of extrinsic rewards on intrinsic motivation. Psychol Bull. 1999 Nov;125(6):627-68; discussion 692-700. doi: 10.1037/0033-2909.125.6.627.

    PMID: 10589297BACKGROUND
  • Mekler ED, Brühlmann F, Opwis K, Tuch AN. Do points, levels and leaderboards harm intrinsic motivation? An empirical analysis of common gamification elements. 2013:66-73.

    BACKGROUND
  • Linehan C, Kirman B, Roche B. Gamification as behavioral psychology. The Gameful world: Approaches, Issues, Applications. MIT Press; 2015:81-105.

    BACKGROUND

Results Point of Contact

Title
Dr. Hollie Raynor
Organization
University of Tennessee, Knoxville

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: 2 x 2 factorial design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Associate Dean of Research & Operations, College of Education, Health, and Human Sciences

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 5, 2024

Study Start

April 4, 2024

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

December 3, 2025

Results First Posted

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations