UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042949 |
|---|---|
| Receipt number | R000049024 |
| Scientific Title | A pilot study to examine the effect of remote nutrition education on the Japan Diet |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2025/01/11 19:31:15 |
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Basic information
Public title
A study to examine the effect of remote nutrition education on the Japan Diet
Acronym
Remote nutrition education study on the Japan Diet
Scientific Title
A pilot study to examine the effect of remote nutrition education on the Japan Diet
Scientific Title:Acronym
Remote nutrition education study on the JD
Region
| Japan |
Condition
Condition
overweight
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of remote nutrition education on the Japan Diet intake using teaching materials which ameliorate predisposing and enabling factors of dieting practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase the Japan Diet pattern score at 3month.
Key secondary outcomes
Body weight decrease or improve serum biochemical parameters
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Face to face internet nutrition counseling will be done at baseline, after 1 and 2 month.
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
| 22 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Male
Key inclusion criteria
BMI>22
Recommended by a study doctor
Key exclusion criteria
1.Smoker, quit smoking less than 6 months
2.Habitual supplement and/or health food user
3.Practicing clinical diet therapy
4.Under medication
5. Live in different dietary environment during intervention
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Chizuko |
| Middle name | |
| Last name | Maruyama |
Organization
Japan Women's University
Division name
Department of Food and Nutrition
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL
03-5981-3428
maruyama@fc.jwu.ac.jp
Public contact
Name of contact person
| 1st name | Chizuko |
| Middle name | |
| Last name | Maruyama |
Organization
Japan Women's University
Division name
Department of Food and Nutrition
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL
03-5981-3428
Homepage URL
maruyama@fc.jwu.ac.jp
Sponsor or person
Institute
Laboratory of Nutrition Education and Clinical nutrition in Japan Women's University
Institute
Department
Personal name
Funding Source
Organization
Rice Stable Supply Support Organization
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
The Ethics Committee for Experimental Research involving Human Subjects of Japan Women's University
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
Tel
03-5981-3773
n-shien@atlas.jwu.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
| 2021 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://mol.medicalonline.jp/archive/search?jo=fl2eiyou&vo=45&nu=4
Publication of results
Unpublished
Result
URL related to results and publications
https://mol.medicalonline.jp/archive/search?jo=fl2eiyou&vo=45&nu=4
Number of participants that the trial has enrolled
39
Results
Intakes of fatty meat were reduced, while unrefined grains, green and yellow vegetables, soybean, and fish doubled. Body weight, umbilical circumference, systolic blood pressure, and blood lipids were reduced. The median frequencies of entering information in the self-monitoring sheet were 4.3 and 4.9 times/w for body weight and each food group intakes, respectively, during the first 4 weeks.
Results date posted
| 2025 | Year | 01 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 21 | Day |
Baseline Characteristics
Age 28.7 +- 4.6 years old, BMI 24.8(23.9, 26.9).
Participant flow
Online individual nutrition education was provided at baseline, after 4 and 8 weeks, with 3 months of follow-up. Participants were instructed to do daily self-monitoring of body weight and intakes of food groups comprising "The Japan Diet" using a spreadsheet application. Fasting anthropometric, blood pressure and blood biochemical parameters were measured, and dietary records, obtained photographically, were submitted at baseline and after 3 months. At the end of the intervention, participants filled out a questionnaire on the educational materials used for the online education including the application system and their understanding of "The Japan Diet".
Adverse events
None
Outcome measures
Body weight, blood pressure, serum glycolipid parameters, liver function, food intake volume, food intake frequency.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049024
