UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062155 |
|---|---|
| Receipt number | R000071129 |
| Scientific Title | Evaluation of a Side-Dish Intake Promotion Intervention on Diet Quality and Psychological Health in Dual-Income Families with Children |
| Date of disclosure of the study information | 2026/07/07 |
| Last modified on | 2026/07/07 11:16:54 |
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Basic information
Public title
Evaluation of a Side-Dish Intake Promotion Intervention on Diet Quality and Psychological Health in Dual-Income Families with Children
Acronym
Evaluation of a Side-Dish Intake Promotion Intervention on Diet Quality and Psychological Health in Dual-Income Families with Children
Scientific Title
Evaluation of a Side-Dish Intake Promotion Intervention on Diet Quality and Psychological Health in Dual-Income Families with Children
Scientific Title:Acronym
Evaluation of a Side-Dish Intake Promotion Intervention on Diet Quality and Psychological Health in Dual-Income Families with Children
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a side-dish intake promotion intervention on diet quality and psychological health outcomes among dual-income families with children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in dietary quality
Key secondary outcomes
Changes in health-related quality of life, work productivity, parent-child relationship, and psychological well-being
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Control group maintaining usual lifestyle without any nutritional education or food provision for 4 weeks.
Interventions/Control_2
Intervention group receiving nutrition education materials or seminar videos and encouragement to increase side-dish intake, with weekly reminders, for 4 weeks.
Interventions/Control_3
Intervention group receiving nutrition education materials, encouragement to increase side-dish intake, and weekly provision of commercially available side-dish products for 4 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents living with elementary or junior high school children
Involved in food purchasing or meal planning
Responsible for preparing dinner at least 3 days per week
Employed (including dual-income or single working parent; >=3 days/week)
Provided informed consent to participate
Key exclusion criteria
Individuals with serious medical conditions (e.g., cardiovascular, gastrointestinal, metabolic)
Those under medical dietary restrictions
Individuals practicing extreme dietary restrictions
Strong aversion to commercially prepared side dishes
Food allergies limiting intake of common side-dish foods
Pregnant, lactating, or planning pregnancy during the study period
Irregular work schedules (e.g., night shifts)
Difficulty responding to questionnaires
Participation in other clinical studies
Planning to join other diet or nutrition programs during the study period
Considered inappropriate by the investigators
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Yayoi |
| Middle name | |
| Last name | Gotoh |
Organization
Fujicco Co., Ltd.,
Division name
Research and Development Department
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Japan
TEL
078-303-5191
y-gotoh@fujicco.co.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Tabata |
Organization
Fujicco Co., Ltd.,
Division name
Research and Development Department
Zip code
650-8558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Japan
TEL
078-303-5191
Homepage URL
y-tabata@fujicco.co.jp
Sponsor or person
Institute
Fujicco Co., Ltd.,
Institute
Department
Personal name
Funding Source
Organization
Fujicco Co., Ltd.,
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujicco Co., Ltd. Biomedical Ethics Committee
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Japan
Tel
078-303-5191
y-tabata@fujicco.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071129
