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

NCT05310162 | Unknown DMC

• 1 other identifier: 1017
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Bruxism, Childhood

Keywords

Children; Sleep bruxism; Added sugar; Screen time

Outcome Measures

Primary Outcomes (1)

• Frecuency of sleep bruxism

  Report from the parents in the CSHQ with values of usually, some times and no/rarely

  8 weeks

Secondary Outcomes (2)

• Frecuency of added sugar consumption

  8 weeks

• Screen time

  8 weeks

Study Arms (2)

Food, fun and family

EXPERIMENTAL

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.

Behavioral: Food, fun and family

Counseling

ACTIVE COMPARATOR

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.

Behavioral: Counseling

Interventions

Food, fun and family BEHAVIORAL

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.

Also known as: FFF

Food, fun and family

Counseling BEHAVIORAL

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.

Counseling

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CES University: lead

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MeSH Terms

Conditions

Sleep Bruxism

Interventions

Food; Counseling

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Claudia C Restrepo, PHD

  CES LPH research group

  PRINCIPAL INVESTIGATOR

• Ruben D Manrique, PHD

  CES LPH research group

  STUDY CHAIR

Central Study Contacts

Claudia C Restrepo, PHD

CONTACT

5744440555; crestrepos@ces.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CES-LPH research group director

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: April 11, 2022
• Primary Completion: December 10, 2022
• Study Completion: May 5, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share