UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049803 |
|---|---|
| Receipt number | R000056712 |
| Scientific Title | Effectiveness of a nutrition education package in improving feeding frequency, dietary diversity and growth of infants and young children in Nepal: a randomized controlled trial |
| Date of disclosure of the study information | 2023/01/05 |
| Last modified on | 2025/06/23 08:14:34 |
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Basic information
Public title
Effectiveness of a nutrition education package in improving feeding frequency, dietary diversity and growth of infants and young children in Nepal: a randomized controlled trial
Acronym
ENEP
Scientific Title
Effectiveness of a nutrition education package in improving feeding frequency, dietary diversity and growth of infants and young children in Nepal: a randomized controlled trial
Scientific Title:Acronym
ENEP
Region
| Japan | Asia(except Japan) |
Condition
Condition
Malnutrition
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this intervention trial is to implement and evaluate the effectiveness of a nutrition education package in improving infant and young child feeding practices, dietary adequacy, and growth.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness of a nutrition education package on feeding practices and dietary adequacy,
To document the process of implementation of the nutrition education package to promote optimal feeding and health practice
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of the study will be linear growth as assessed by mean change in LAZ of age accordingly.
Key secondary outcomes
Mean change in weight and weight-for-length Z-scores (WLZ),
The proportion of children consuming foods from 4 or more food groups,
The proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day and Improved Maternal level of knowledge and practice of recommended feeding and health practices
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The intervention group will receive Nutrition education along with Routine health education.
Interventions/Control_2
The control group will receive routine health 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
| 6 | months-old | <= |
Age-upper limit
| 2 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
6 months to 2 years infants and young children along with their parents (or caregivers) who are residents in the sampled village and have no plans to move away during the intervention period.
Key exclusion criteria
Infants with obvious congenital or chronic abnormalities,
Impairing feeding or physical growth measurements,
have edema; are severely ill or have clinical complications warranting hospitalization.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Minato |
| Middle name | |
| Last name | Nakazawa |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
6540142
Address
7-10-2 Tomogakoa, Suma-Ku, Kobe, Japan
TEL
078-792-2555
minato-nakazawa@people.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Seeta |
| Middle name | |
| Last name | Baral Basnet |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
6580013
Address
Hyogo ken, Kobe shi, Higasinadaku Fukae Kitamachi 2-2-9-108
TEL
09092190894
Homepage URL
seetabaralbaral@gmail.com
Sponsor or person
Institute
Graduate School of Health Sciences, Kobe University
Institute
Department
Personal name
Funding Source
Organization
This study is a self-funded study by the researcher.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University
Address
7-10-2 Tomogaoka, Suma-ku, Kobe 654-0142 Japan
Tel
+81(0)78-792-2555
seetabaralbaral@gmail.com
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
Kobe University (Kobe)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 02 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
The data has successfully been collected, and data entry is completed. Now the data analysis is in progress and expected to be completed by January 2025. As soon as the data is analyzed it will be uploaded in UMIN.The manuscript has been completed and soon the results will be uploaded.
Management information
Registered date
| 2022 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056712
