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

Not Applicable

• Conditions: Sleep Bruxism, Childhood
• Interventions: Behavioral: Food, fun and family; Behavioral: Counseling

• Registration Number: NCT05310162
• Lead Sponsor: CES University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-03-25
• Last Update Submitted: 2022-03-25
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Study Start: 2022-04-11
• Primary Completion: 2022-12-10
• Study Completion: 2023-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food, fun and family	Food, fun and family	This intervention aims to change eating and screen time habits in children to decrease the amount of added sugar consumed and the time spent using recreational screens, this with guides and precise instructions given to the parents to have a healthier lifestyle.
Counseling	Counseling	The parents will receive simple verbal instructions to reduce the consumption of added sugar and recreational screen time, giving advice on which foods to avoid and the amount of time permitted for the use of screens.

Primary Outcome Measures

Name	Time	Method
Frecuency of sleep bruxism	8 weeks	Report from the parents in the CSHQ with values of usually, some times and no/rarely

Secondary Outcome Measures

Name	Time	Method
Frecuency of added sugar consumption	8 weeks	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
Screen time	8 weeks	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