UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052442 |
|---|---|
| Receipt number | R000059856 |
| Scientific Title | Intervention to improve supporting skills of dietitians in lifestyle modification: a feasibility trial using a skills checklist |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2024/04/12 15:40:47 |
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Basic information
Public title
Intervention to improve the counseling skills of registered dietitians: a feasibility trial
Acronym
Intervention to improve the counseling skills of registered dietitians: a feasibility trial
Scientific Title
Intervention to improve supporting skills of dietitians in lifestyle modification: a feasibility trial using a skills checklist
Scientific Title:Acronym
Intervention to improve supporting skills of dietitians in lifestyle modification: a feasibility trial using a skills checklist
Region
| Japan |
Condition
Condition
Registered dietitians with less than five years of experience to provide nutritional counseling for metabolic syndrome, diabetes, etc.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of a skills improvement intervention program using a skills checklist for lifestyle modification support in less experienced dietitians.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pre- and post-intervention mean change in the percentages of items that respondents answered they have mostly done out of all checkpoints in the two parts of a skills checklist (Nutrition Assessment and Nutrition Diagnosis).
Key secondary outcomes
1. Pre-and post-intervention changes in the percentages of items that respondents answered they have mostly done out of all checkpoints in the other parts except primary outcome
2. Pre-and post-intervention changes in anxiety and confidence based on the questionnaire about their own nutrition counseling skills
3. Agreement between the dietitian's self-assessment using a skills checklist and the objective judgment by the evaluator
4. Percentage of study participants completing the intervention
5. Percentage of missing measurements or invalid responses
6. Accumulation rate of study participants
7. Distribution of self-assessment scores on a skills checklist
8. Amount of change before and after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention method is to assign registered dietitians to self-study to improve their skills over three months. For this period, registered dietitians will be required to self-assess their lifestyle improvement support skills using a skills checklist every two weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have a national qualification as a registered dietitian and have less than 5 years of experience in nutrition counseling.
2. Registered dietitians who belong to medical institutions, pharmacies, specified health guidance business operators, etc. and provide nutritional counseling such as outpatient nutrition dietary guidance and specified health guidance, and who provide nutritional counseling multiple times and continuously to each client.
3. Those who have given written informed consent of their own free will with sufficient understanding after receiving an explanation for the research.
Key exclusion criteria
1. Those who cannot obtain consent
2. Those who do not do continuous nutrition counseling (those who do nutrition counseling after only one intervention)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Suzuki |
Organization
Teikyo University Graduate School of Public Health
Division name
Teikyo University Graduate School of Public Health
Zip code
173-0003
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211(46214)
asuka-suzuki@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Adachi |
Organization
Nutrition Support Network LLC
Division name
Nutrition Support Network LLC
Zip code
252-0334
Address
2-2-4 Wakamatsu, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-765-6393
Homepage URL
adachi@nutrisupport.co.jp
Sponsor or person
Institute
Teikyo University Graduate School of Public Health
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Medical Research Ethics Committee
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
Tel
03-3964-1211(ext.46214)
turb-office@teikyo-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
| 2023 | Year | 10 | Month | 10 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059856
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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