UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044469
Receipt No. R000050799
Scientific Title Influence of remote nutrition education on meals and nutritional indicators in young women: randomized controlled trials
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/08

* 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 Influence of remote nutrition education using SNS on meals and nutritional indicators in young women
Acronym Usefulness of remote nutrition education using SNS for young women
Scientific Title Influence of remote nutrition education on meals and nutritional indicators in young women: randomized controlled trials
Scientific Title:Acronym Usefulness of remote nutrition education for young women
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effects of remote nutrition education using digital technology on the eating habits, eating behavior, nutrition intake, muscle mass, and muscle strength of young women for improving their dietary habits.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the balance of nutrition intake (ratio of skipping breakfast, ratio of %protein intake / energy intake of breakfast, 24-hour urinary sodium/potassium ratio) after 3 and 12 months of intervention.
Key secondary outcomes Changes in body composition, 24-hour urinary nitrogen excretion and pH, muscle strength, and eating behavior after 3 and/or 12 months of intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group receiving nutrition education
Interventions/Control_2 Control group not receiving nutrition education
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
18 years-old <=
Age-upper limit
25 years-old >=
Gender Female
Key inclusion criteria Participants are healthy female students with no physical, mental, or social difficulties who can give consent for the study.
Key exclusion criteria 1) Those who have diseases such as circulatory, metabolic, or renal diseases, and are receiving medication or treatment from medical doctors
2) Those who are pregnant or lactating.
3) Those who request to withdraw
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kenichiro
Middle name
Last name Yasutake
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 814-0198
Address 5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL 092-851-2531
Email yasutake@nakamura-u.ac.jp

Public contact
Name of contact person
1st name Kenichiro
Middle name
Last name Yasutake
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 814-0198
Address 5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL 092-851-2531
Homepage URL
Email yasutake@nakamura-u.ac.jp

Sponsor
Institute Nakamura Gakuen University
Institute
Department

Funding Source
Organization Nakamura Gakuen University
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 Cooperation Promotion Department, Nakamura Gakuen University
Address 5-7-1 Befu Jonan-ku, Fukuoka, Japan
Tel 092-851-5579
Email kks@nakamura-u.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 07 Month 01 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
2021 Year 06 Month 04 Day
Date of IRB
2021 Year 06 Month 04 Day
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2023 Year 12 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
2021 Year 06 Month 08 Day
Last modified on
2021 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050799

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.