UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050960 |
|---|---|
| Receipt number | R000058088 |
| Scientific Title | Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Parents and Children Using Child Development Support and After-School Day Care Services |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2025/04/01 16:50:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Parents and Children Using Child Development Support and After-School Day Care Services
Acronym
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Children with Developmental Disabilities and Their Parents
Scientific Title
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Parents and Children Using Child Development Support and After-School Day Care Services
Scientific Title:Acronym
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Children with Developmental Disabilities and Their Parents
Region
| Japan |
Condition
Condition
Children with developmental disabilities and Down syndrome and their parents
Classification by specialty
| Pediatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the dietary intake, food preferences, and intestinal microflora of children with developmental disabilities and their parents, and to clarify the impact of providing nutrition education support.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate food intake, defecation status, and bowel habits after implementation of nutrition education
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Examine nutrition education support content and implement nutrition education based on the results of the questionnaire survey on food preferences.
Interventions/Control_2
Interventions/Control_3
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
| 4 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parents and children using child development support and after-school day care services in Niigata City
Key exclusion criteria
Those that ceased to use the facility during the study period.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, niigata,JAPAN
TEL
+81-25-257-4494
takeuchi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, niigata,JAPAN
TEL
025-257-4494
Homepage URL
takeuchi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, niigata,JAPAN
Tel
025-257-4494
takeuchi@nuhw.ac.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
| 2023 | Year | 05 | Month | 08 | 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
8
Results
The parents of children with ASD have tried various responses, but have not seen any effect. On the other hand, there were many responses that had not been tried, suggesting that food support is important. In addition, in ASD children, nutrition education in small groups had an impact on both children and parents.
Results date posted
| 2025 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Child Development Support Centers and after-school day care services (hereafter referred to as child development and after-school day care) are one of the welfare services for children with disabilities as stipulated in the Child Welfare Law. It offers programs to help children acquire the skills necessary for daily and group living, as well as support in cooperation with the community, preschools, and homes. Developmental disabilities include autistic spectrum disorder (ASD), learning disability, attention deficit, and hyperactivity disorder. ASD is a developmental disability with two basic characteristics: impaired interpersonal relationships and social interaction and obsessive behavior. Because of their obsessive behavior, children with ASD are reported to have many problems with eating behavior, and they also have many gastrointestinal symptoms. Recently, the relationship between intestinal microbiota and behaviors characteristic of children with ASD has also been pointed out. Although previous studies have reported on unbalanced diets in children with ASD and on the bacterial community in children with ASD, there are few reports on parents' responses to unbalanced diets and food difficulties, responses of children with ASD to nutrition education, and nutrition education effects (changes in unbalanced diets, changes in digestive symptoms, etc.), and many aspects are not yet clarified. Therefore, we thought that nutrition education for children with ASD was important in this context.
Participant flow
1 . Subjects
The target population consisted of infants and children who use the Kopanhasu Niigata Central Branch and their parents or guardians, and eight people who agreed to participate in the study. The subjects were asked to write a letter to the parents of the infants and children explaining the outline, purpose, and methods of the research; the benefits, burdens, and risks of participation, and how to deal with them; the handling and protection of personal information; the provision and publication of information related to the research; and the disadvantages and conflicts of interest of not participating in the research. We obtained the parents' consent on the consent form. This research will be conducted in August 2023 at the Niigata University of Health and Welfare.
This research was approved by the Ethical Review Research Plan submitted to the Ethical Review Committee of Niigata University of Health and Welfare in August 2023 (Approval No. 19057-230529).
2. Research Method
We conducted a questionnaire survey from May to June 2023, and conducted dietary education from May to September 2003.
1) Questionnaire Survey
The questionnaire survey was conducted on the parents of infants and children, and included the following questions: A. Basic information (relationship with the child being surveyed, time available for the respondent to answer questions, date of birth, sex, height, weight, birth order, and diagnosis of the infant or child being surveyed), B. Parents were asked about the infant's or child's diet, and whether they had any problems with food, if they had difficulty coping with food, and breakfast intake, and if they had any questions about their child's eating habits. Parents' concerns about meals, mealtime difficulties, breakfast intake
C. The health status and living habits (body size, teeth, frequency of bowel movements) of the infants and children were surveyed.
2) Nutrition education
Based on the results of the parent questionnaire survey, we conducted four sessions of nutrition education focusing on shortened mealtimes, overcoming food preferences, and bowel movements. It is difficult for ASD children and their parents to conduct food education such as shopping, touching food materials, and cooking together, which they can do at home every day.
Therefore, we planned a program that could be implemented at the child development support centers and after-school day services, and that would allow children to take home what they made through the food education program and share it with their parents. The program was also designed to integrate the senses (sight, sound, taste, smell, and touch)5) . Sensory integration refers to the brain's ability to organize the various sensory information that enters the brain according to its purpose and to formulate it into a well-ordered structure.
In the second and third sessions, it became clear that many of the children had an aversion to vegetables, and so we began to focus on the role of the brain in organizing and ordering sensory information according to purpose.
In the second and third sessions, it became clear that many of the children disliked vegetables, so we used vegetables in the nutrition education program. To familiarize the children with vegetables, we started by having them touch and smell the vegetables, put their faces on the vegetables with a seal, made vegetable stamps, and stamped the stamps on paper. The fourth session focused on natto (fermented soybeans) because of the problems of unbalanced diets and aversion to natto.
Adverse events
No adverse circumstances occurred.
Outcome measures
It was clear that children with autism spectrum disorder tend to have more unbalanced diets and do not eat as much as other children, even when food preparation and environment are carefully controlled.
As for the impact of nutrition education, the children showed behaviors such as touching and putting food in their mouths that they were uncomfortable with after repeated sessions of nutrition education.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058088
