An interventional study of Food, fun and family and Counseling in Sleep Bruxism, Childhood, sponsored by CES University. Status unknown. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by CES University · Not applicable, Interventional, and Treatment
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.
62 studies on the registry are indexed under Sleep Bruxism; 11 are open to participants now.
This study's planned enrollment of 80 is above the median of 39 across 38 interventional studies indexed under Sleep Bruxism.
Browse Sleep Bruxism studies →CES University is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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
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.
Frecuency of sleep bruxism
Report from the parents in the CSHQ with values of usually, some times and no/rarely
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: No
Start is estimated for Apr 2022; primary completion for Dec 2022, 7 months later.
Of 19 interventional studies with no phase under Sleep Bruxism, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's planned 7 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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CES University