Obesity, Childhood Clinical Trial
Official title:
Enhancing Child Digital Dietary Self-monitoring: Proof-of-concept Trial
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 with overweight or obesity and their adult caregivers. - Examine the acceptability of a dDSM log that uses positive reinforcement (praise and gamification) among children 8-12 years with overweight or obesity 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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 100 Years |
Eligibility | Inclusion Criteria: - Families with children ages 8-12 years with overweight and obesity [defined as body mass index (BMI)-for-age = 85th 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The University of Tennessee, Knoxville |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Favell JE. The power of positive reinforcement: a handbook of behavior modification. Charles C Thomas; 1977.
Freeman 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.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Linehan C, Kirman B, Roche B. Gamification as behavioral psychology. The Gameful world: Approaches, Issues, Applications. MIT Press; 2015:81-105.
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.
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. — View Citation
Saelens BE, McGrath AM. Self-monitoring adherence and adolescent weight control efficacy. Children's Health Care. 2003;32(2):137-152.
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. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dietary self-monitoring 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. | 4 weeks | |
Primary | Dietary self-monitoring 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. | 4 weeks | |
Primary | 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. | 4 weeks | |
Secondary | 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 the log with the research assistant so that he or she has some familiarity with the behavior before completing the measure. | 4 weeks | |
Secondary | 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. | 4 weeks | |
Secondary | 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, sugar sweetened beverages), glycemic load and glycemic index. It takes approximately 10-12 minutes to complete. | 4 weeks |
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