Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062317) titled 'Investigation of the impact of potato salad preparation on hormone secretion - A single-arm pre-post comparative study' on July 24.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Kewpie Corporation
Condition:
Condition - Healthy children and their parents
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effects of cooking activities using potato salad on salivary oxytocin and cortisol concentrations in elementary school children (aged 6 to 12 years) and their parents. By focusing on parent-child interactions specifically, children's proactive cooking challenges and parents' supportive observation we will investigate whether this experience improves children's vegetable intake. Furthermore, the study seeks to clarify the impact of these activities on building a trusting parent child relationship.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Cooking activities using potato salad (child-led cooking and parent's observation) Under the guidance and assistance of the research staff, subjects will prepare an arranged potato salad. During the cooking process, parents will observe their children, providing encouragement and setting an environment that allows the children to proactively engage in the activities.
Eligibility:
Age-lower limit - 6
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Elementary school children (1st to 6th grade, aged 6 to 12 years) and their parents/guardians.
2.Those whose parents/guardians have received sufficient explanation about this study, understood its contents, and provided written informed consent to participate.
3.Those who (the subjects themselves) have understood the study contents and provided assent to participate (depending on their age and level of understanding).
4.Those who are able to visit the designated study site on the day of the study.
Key exclusion criteria - 1.Those who have a physician-diagnosed food allergy to the ingredients to be used in this study (e.g., eggs, wheat, soybeans).
2.Those with severe cardiac, endocrine, or psychiatric disorders, etc.
3.Those who regularly take medications that may affect hormone secretion.
4.Pregnant or breastfeeding parents (Due to altered hormone secretion dynamics, they will be excluded from the primary outcome [saliva collection] and participate only in the secondary outcomes [questionnaires]. Note: Their corresponding children will undergo all measurements as usual).
5.Others deemed inappropriate as study subjects by the principal investigator.
Target Size - 96
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 07 Month 08 Day
Date of IRB - 2026 Year 07 Month 09 Day
Anticipated trial start date - 2026 Year 07 Month 09 Day
Last follow-up date - 2026 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071315
Disclaimer: Curated by HT Syndication.