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

Primary Purpose

Sleep Bruxism, Childhood

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Food, fun and family
Counseling
Sponsored by
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Bruxism, Childhood focused on measuring Children, Sleep bruxism, Added sugar, Screen time

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Food, fun and family

    Counseling

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    March 25, 2022
    Last Updated
    March 25, 2022
    Sponsor
    CES University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05310162
    Brief Title
    Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children
    Official Title
    Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 11, 2022 (Anticipated)
    Primary Completion Date
    December 10, 2022 (Anticipated)
    Study Completion Date
    May 5, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CES University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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 SantamarΓ­a. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Bruxism, Childhood
    Keywords
    Children, Sleep bruxism, Added sugar, Screen time

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Food, fun and family
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Counseling
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Food, fun and family
    Other Intervention Name(s)
    FFF
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Counseling
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Frecuency of sleep bruxism
    Description
    Report from the parents in the CSHQ with values of usually, some times and no/rarely
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Frecuency of added sugar consumption
    Description
    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
    Time Frame
    8 weeks
    Title
    Screen time
    Description
    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
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Claudia C Restrepo, PHD
    Phone
    5744440555
    Ext
    1550
    Email
    crestrepos@ces.edu.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudia C Restrepo, PHD
    Organizational Affiliation
    CES LPH research group
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ruben D Manrique, PHD
    Organizational Affiliation
    CES LPH research group
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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