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

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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

Email

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


Email

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

Email

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