Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children

Sleep Bruxism, Childhood Clinical Trial

Official title:

Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05310162
• Other study ID #: 1017
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: March 2022
• Source: CES University
• Contact: Claudia C Restrepo, PHD
• Phone: 5744440555
• Email: crestrepos[@]ces.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Excess consumption of refined sugar and increased use of recreational screen time are risk factors for alterations in the quality of life that have been associated with sleep bruxism in children and that compromise the same mechanisms of alteration of the reward system in the brain. Therefore, the question of this research is: What is the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in children? The general objective of the research is to evaluate the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in 84 children who attend the pediatric dentistry postgraduate clinic of the CES University and the private consultation Dr. Claudia Restrepo and Dr. Adriana Santamaría. The frequency of sleep bruxism will be evaluated with the translated and validated Spanish version of the Children's Sleep Habits Questionnaire (CSHQ), which will be answered by the parents. The consumption of added sugar will be evaluated with the version translated into Spanish of the Health Behavior in School-Aged Children - Food-Frequency Questionnaire (HBSC-FFQ). The time on screens will be recorded through the parents' report, of the time in hours that the child spends using electronic media in a recreational way each weekday for a week and each weekend day for a week.

A decrease in the frequency of sleep bruxism is expected to be found by reducing sugar consumption and screen time in the children evaluated.

The results of this study will be presented at the IADR, ACFO, ACOP and CES University research meetings and will be published in a peer-reviewed scientific journal in category Q1.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 5, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children who eat breakfast, lunch and dinner at home.

• Children whose feeding and habits management (upbringing) is in charge of the same group of representative adults.

• Children who live with their parents.

• Children attending the consultation for the first time.

Exclusion Criteria:

• Symptoms of respiratory disorders reported by parents in the CSHQ.

• Food allergies.

• Special diet restrictions.

• Developmental disorder influencing diet or weight.

• Basic endocrinological diseases.

• Being under endocrinological treatment.

• Previously diagnosed sleep disorders.

• Children who miss more than two assigned appointments.

• Parents of children who withdraw informed consent.

• Children who are diagnosed during the study with respiratory disorders.

• Children who are diagnosed during the study with food allergies.

• Children who for personal reasons cannot continue in the study.

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism
• Sleep Bruxism, Childhood

Intervention

Behavioral:
• Food, fun and family
The intervention consists of a series of change of habits in the way children eat, the reduction of the recreational time of screens and healthy habits of physical activity. This intervention, which is called "Food, Fun & Family (FFF)", is aimed at parents and has been shown to be effective in reducing the consumption of "empty calories" by children. It teaches parents skills to reduce their daily energy intake of added sugars and saturated fats, it also seeks to reduce screen time. The intervention contains information and recommendations, through guides, in which precise instructions are given about how to maintain a healthy environment at home.
• Counseling
Simple verbal instructions will be given in the consultation to reduce the time of use of screens and refined sugar. For refined sugar reduction, parents will be told to avoid sugary drinks, add sugar to drinks (juices, milk, etc.), and avoid snacks and sweets. It will also be indicated that the screen time should be less than two hours a day and in no case use them two hours before sleeping.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CES University

References & Publications (36)

Bach SL, Moreira FP, Goettems ML, Brancher LC, Oses JP, da Silva RA, Jansen K. Salivary cortisol levels and biological rhythm in schoolchildren with sleep bruxism. Sleep Med. 2019 Feb;54:48-52. doi: 10.1016/j.sleep.2018.09.031. Epub 2018 Oct 28. — View Citation

Cohen JFW, Rifas-Shiman SL, Young J, Oken E. Associations of Prenatal and Child Sugar Intake With Child Cognition. Am J Prev Med. 2018 Jun;54(6):727-735. doi: 10.1016/j.amepre.2018.02.020. Epub 2018 Apr 16. — View Citation

Del-Ponte B, Quinte GC, Cruz S, Grellert M, Santos IS. Dietary patterns and attention deficit/hyperactivity disorder (ADHD): A systematic review and meta-analysis. J Affect Disord. 2019 Jun 1;252:160-173. doi: 10.1016/j.jad.2019.04.061. Epub 2019 Apr 10. — View Citation

Ervin RB, Kit BK, Carroll MD, Ogden CL. Consumption of added sugar among U.S. children and adolescents, 2005-2008. NCHS Data Brief. 2012 Mar;(87):1-8. — View Citation

Fisberg M, Kovalskys I, Gómez G, Rigotti A, Sanabria LYC, García MCY, Torres RGP, Herrera-Cuenca M, Zimberg IZ, Koletzko B, Pratt M, Aznar LAM, Guajardo V, Fisberg RM, Sales CH, Previdelli ÁN; ELANS Study Group. Total and Added Sugar Intake: Assessment in Eight Latin American Countries. Nutrients. 2018 Mar 22;10(4). pii: E389. doi: 10.3390/nu10040389. — View Citation

Fisher JO, Serrano EL, Foster GD, Hart CN, Davey A, Bruton YP, Kilby L, Harnack L, Ruth KJ, Kachurak A, Lawman HG, Martin A, Polonsky HM. Title: efficacy of a food parenting intervention for mothers with low income to reduce preschooler's solid fat and added sugar intakes: a randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Jan 17;16(1):6. doi: 10.1186/s12966-018-0764-3. — View Citation

Guideline: Sugars Intake for Adults and Children. Geneva: World Health Organization; 2015. — View Citation

Hale L, Guan S. Screen time and sleep among school-aged children and adolescents: a systematic literature review. Sleep Med Rev. 2015 Jun;21:50-8. doi: 10.1016/j.smrv.2014.07.007. Epub 2014 Aug 12. Review. — View Citation

Horowitz-Kraus T, Hutton JS. Brain connectivity in children is increased by the time they spend reading books and decreased by the length of exposure to screen-based media. Acta Paediatr. 2018 Apr;107(4):685-693. doi: 10.1111/apa.14176. Epub 2017 Dec 27. — View Citation

Lavigne GJ, Kato T, Kolta A, Sessle BJ. Neurobiological mechanisms involved in sleep bruxism. Crit Rev Oral Biol Med. 2003;14(1):30-46. Review. — View Citation

Lissak G. Adverse physiological and psychological effects of screen time on children and adolescents: Literature review and case study. Environ Res. 2018 Jul;164:149-157. doi: 10.1016/j.envres.2018.01.015. Epub 2018 Feb 27. Review. — View Citation

Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21. — View Citation

Manfredini D, Lobbezoo F, Giancristofaro RA, Restrepo C. Association between proxy-reported sleep bruxism and quality of life aspects in Colombian children of different social layers. Clin Oral Investig. 2017 May;21(4):1351-1358. doi: 10.1007/s00784-016-1901-5. Epub 2016 Jul 14. — View Citation

Manfredini D, Restrepo C, Diaz-Serrano K, Winocur E, Lobbezoo F. Prevalence of sleep bruxism in children: a systematic review of the literature. J Oral Rehabil. 2013 Aug;40(8):631-42. doi: 10.1111/joor.12069. Epub 2013 May 24. Review. — View Citation

Moynihan P, Makino Y, Petersen PE, Ogawa H. Implications of WHO Guideline on Sugars for dental health professionals. Community Dent Oral Epidemiol. 2018 Feb;46(1):1-7. doi: 10.1111/cdoe.12353. Epub 2017 Nov 23. Review. — View Citation

Newens KJ, Walton J. A review of sugar consumption from nationally representative dietary surveys across the world. J Hum Nutr Diet. 2016 Apr;29(2):225-40. doi: 10.1111/jhn.12338. Epub 2015 Oct 10. Review. — View Citation

Orgilés M, Owens J, Espada JP, Piqueras JA, Carballo JL. Spanish version of the Sleep Self-Report (SSR): factorial structure and psychometric properties. Child Care Health Dev. 2013 Mar;39(2):288-95. doi: 10.1111/j.1365-2214.2012.01389.x. Epub 2012 Jun 8. — View Citation

Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51. — View Citation

Radesky JS, Christakis DA. Increased Screen Time: Implications for Early Childhood Development and Behavior. Pediatr Clin North Am. 2016 Oct;63(5):827-39. doi: 10.1016/j.pcl.2016.06.006. Review. — View Citation

Ramos-Lopez O, Panduro A, Rivera-Iñiguez I, Roman S. Dopamine D2 receptor polymorphism (C957T) is associated with sugar consumption and triglyceride levels in West Mexicans. Physiol Behav. 2018 Oct 1;194:532-537. doi: 10.1016/j.physbeh.2018.07.004. Epub 2018 Jul 4. — View Citation

Restrepo C, Manfredini D, Lobbezoo F. Sleep behaviors in children with different frequencies of parental-reported sleep bruxism. J Dent. 2017 Nov;66:83-90. doi: 10.1016/j.jdent.2017.08.005. Epub 2017 Aug 12. — View Citation

Restrepo C, Santamaría A, Manrique R. Sleep bruxism in children: relationship with screen-time and sugar consumption. Sleep Med X. 2021 Apr 24;3:100035. doi: 10.1016/j.sleepx.2021.100035. eCollection 2021 Dec. — View Citation

Roberts CA, Giesbrecht T, Fallon N, Thomas A, Mela DJ, Kirkham TC. A Systematic Review and Activation Likelihood Estimation Meta-Analysis of fMRI Studies on Sweet Taste in Humans. J Nutr. 2020 Jun 1;150(6):1619-1630. doi: 10.1093/jn/nxaa071. — View Citation

Scariot R, Brunet L, Olsson B, Palinkas M, Regalo SCH, Rebellato NLB, Brancher JA, Torres CP, Diaz-Serrano KV, Küchler EC, Zielak JC. Single nucleotide polymorphisms in dopamine receptor D2 are associated with bruxism and its circadian phenotypes in children. Cranio. 2022 Mar;40(2):152-159. doi: 10.1080/08869634.2019.1705629. Epub 2019 Dec 23. — View Citation

Schulze MB, Manson JE, Ludwig DS, Colditz GA, Stampfer MJ, Willett WC, Hu FB. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA. 2004 Aug 25;292(8):927-34. — View Citation

Shqair AQ, Pauli LA, Costa VPP, Cenci M, Goettems ML. Screen time, dietary patterns and intake of potentially cariogenic food in children: A systematic review. J Dent. 2019 Jul;86:17-26. doi: 10.1016/j.jdent.2019.06.004. Epub 2019 Jun 19. — View Citation

Sim E, Sohn W, Choi ES, Noh H. Sugar-sweetened beverage consumption frequency in Korean adolescents: based on the 2015 Youth Risk Behavior Web-Based Survey. Int Dent J. 2019 Oct;69(5):376-382. doi: 10.1111/idj.12485. Epub 2019 May 11. — View Citation

Souto-Souza D, Mourão PS, Barroso HH, Douglas-de-Oliveira DW, Ramos-Jorge ML, Falci SGM, Galvão EL. Is there an association between attention deficit hyperactivity disorder in children and adolescents and the occurrence of bruxism? A systematic review and meta-analysis. Sleep Med Rev. 2020 Oct;53:101330. doi: 10.1016/j.smrv.2020.101330. Epub 2020 May 19. — View Citation

Türkoglu S, Akça ÖF, Türkoglu G, Akça M. Psychiatric disorders and symptoms in children and adolescents with sleep bruxism. Sleep Breath. 2014 Sep;18(3):649-54. doi: 10.1007/s11325-013-0928-y. Epub 2013 Dec 28. — View Citation

Twenge JM, Campbell WK. Associations between screen time and lower psychological well-being among children and adolescents: Evidence from a population-based study. Prev Med Rep. 2018 Oct 18;12:271-283. doi: 10.1016/j.pmedr.2018.10.003. eCollection 2018 Dec. — View Citation

van Loveren C. Sugar Restriction for Caries Prevention: Amount and Frequency. Which Is More Important? Caries Res. 2019;53(2):168-175. doi: 10.1159/000489571. Epub 2018 Aug 8. Review. — View Citation

Vélez AL, Restrepo CC, Peláez-Vargas A, Gallego GJ, Alvarez E, Tamayo V, Tamayo M. Head posture and dental wear evaluation of bruxist children with primary teeth. J Oral Rehabil. 2007 Sep;34(9):663-70. — View Citation

Vereecken CA, Maes L. A Belgian study on the reliability and relative validity of the Health Behaviour in School-Aged Children food-frequency questionnaire. Public Health Nutr. 2003 Sep;6(6):581-8. — View Citation

Weinstein A, Livny A, Weizman A. New developments in brain research of internet and gaming disorder. Neurosci Biobehav Rev. 2017 Apr;75:314-330. doi: 10.1016/j.neubiorev.2017.01.040. Epub 2017 Feb 11. Review. — View Citation

Wittekind A, Walton J. Worldwide trends in dietary sugars intake. Nutr Res Rev. 2014 Dec;27(2):330-45. doi: 10.1017/S0954422414000237. Review. — View Citation

Yen JY, Ko CH, Yen CF, Wu HY, Yang MJ. The comorbid psychiatric symptoms of Internet addiction: attention deficit and hyperactivity disorder (ADHD), depression, social phobia, and hostility. J Adolesc Health. 2007 Jul;41(1):93-8. Epub 2007 Apr 12. — View Citation

* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frecuency of sleep bruxism	Report from the parents in the CSHQ with values of usually, some times and no/rarely	8 weeks
Secondary	Frecuency of added sugar consumption	Report from the parents with the Spanish translated version of the HBSC-FFQ with values of never, less than one time a week, once a week, four days a week, five to six times a week, once a day every day, more than one a day	8 weeks
Secondary	Screen time	Report from the parents of time in hours spent in front of audiovisuals, every day of the week during a week and each day of the weekend during a weekend	8 weeks