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

March 25, 2022 updated by: Claudia Cecilia Restrepo Serna, CES University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

Other Names:
  • FFF
Active Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frecuency of sleep bruxism
Time Frame: 8 weeks
Report from the parents in the CSHQ with values of usually, some times and no/rarely
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frecuency of added sugar consumption
Time Frame: 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
8 weeks
Screen time
Time Frame: 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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CES University

Investigators

  • Principal Investigator: Claudia C Restrepo, PHD, CES LPH research group
  • Study Chair: Ruben D Manrique, PHD, CES LPH research group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 11, 2022

Primary Completion (Anticipated)

December 10, 2022

Study Completion (Anticipated)

May 5, 2023

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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