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)

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* 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