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

Sponsor
CES University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05310162
Collaborator
(none)
80
Enrollment
2
Arms
12.8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Food, fun and family
  • Behavioral: Counseling
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children
Anticipated Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
May 5, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CES University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Claudia Cecilia Restrepo Serna, CES-LPH research group director, CES University
    ClinicalTrials.gov Identifier:
    NCT05310162
    Other Study ID Numbers:
    • 1017
    First Posted:
    Apr 4, 2022
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Claudia Cecilia Restrepo Serna, CES-LPH research group director, CES University
    Children
    Sleep bruxism
    Added sugar
    Screen time
    Additional relevant MeSH terms:
    Bruxism
    Sleep Bruxism

    Study Results

    No Results Posted as of Apr 4, 2022