Clinical Trial: Verification of the effect of improving parent-child relationships when Calpis joint production experiences are carried out multiple times - Continuous use test - (Japan)

Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058665) titled 'Verification of the effect of improving parent-child relationships when Calpis joint production experiences are carried out multiple times - Continuous use test -' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - Macromill, Inc.

Condition: Condition - Healthy voluntee Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - By repeatedly conducting an experience in which parents and children collaboratively create and taste "Calpis" beverages, and comprehensively analyzing psychological scale questionnaires administered before and after the experience and communication features obtained during the experience, the factors that contribute to a good parent-child relationship, the interrelationships between them, and the impact that the continuation of the experience has on the parent-child relationship will be clarified. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Parents and children make and drink "Calpis" beverages for 8 weeks Interventions/Control_2 - Live a normal life without drinking "Calpis" beverages

Eligibility: Age-lower limit - 4 years-old = Gender - Male and Female Key inclusion criteria - 1)The participants must be one child between the ages of 4 (preschool age) and 3rd grade of elementary school, of Japanese nationality, and live in the Tokyo metropolitan area, and one parent. 2)Those who do not drink Calpis on a daily basis Key exclusion criteria - 1)Families with children with developmental disabilities or mental illnesses (because the purpose of the study is to understand the general state of parent-child relationships) 2)People who cannot drink Calpis 3)Families with children who drink Calpis on a daily basis 4)People who are allergic to Calpis, dairy products, or soybeans 5)People who do not agree with the purpose or content of the study 6)People who have significant difficulty communicating in Japanese 7)People who have previously participated in a similar study and are deemed to have the potential to influence the results 8)People with significant facial trauma, inflammation, swelling, or dermatologic disease 9)People whose facial movements (e.g., smiling) are restricted due to an underlying medical condition Target Size - 66

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 31 Day Date of IRB - 2025 Year 07 Month 31 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067068

Disclaimer: Curated by HT Syndication.