UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033546 |
|---|---|
| Receipt number | R000038252 |
| Scientific Title | Effect of Psychosocial Stimulation on Improving Home Environment and Infant Development in West Sumatera, Indonesia |
| Date of disclosure of the study information | 2018/08/30 |
| Last modified on | 2018/07/28 08:09:04 |
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Basic information
Public title
Effect of Psychosocial Stimulation on Improving Home Environment and Infant Development in West Sumatera, Indonesia
Acronym
Effect of Psychosocial Stimulation on Improving Home Environment and Infant Development in West Sumatera, Indonesia
Scientific Title
Effect of Psychosocial Stimulation on Improving Home Environment and Infant Development in West Sumatera, Indonesia
Scientific Title:Acronym
Effect of Psychosocial Stimulation on Improving Home Environment and Infant Development in West Sumatera, Indonesia
Region
| Asia(except Japan) |
Condition
Condition
Retrospectively registered
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To asses effect of food supplementation and psycho social social stimulation on growth and development of infants aged 6 - 9 month
Basic objectives2
Others
Basic objectives -Others
To asses effect of psycho social stimulation on improving Home environment and infant development
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increasing Growth and development of infants after six month of intervention
Key secondary outcomes
difference of score Home Environment of infants after six month intervention
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food supplementation/Control
Interventions/Control_2
Psycho social Stimulation/Control
Interventions/Control_3
Food Supplementation + Psycho social/Control
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
| 18 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Health infants aged 6-9 months
Key exclusion criteria
Sick infants or with chronic conditions, they are those infants with malnutrition and congenital defects
Target sample size
356
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr.Helmizar |
Organization
Andalas University Padang
Division name
Department of Nutrition Faculty of Public Health
Zip code
Address
Jalan Perintis Kemerdekaan No 94 Jati Padang
TEL
08126776930
eelbiomed@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr.Helmizar |
Organization
Andalas University Padang
Division name
Department of Nutrition Faculty of Public Health
Zip code
Address
Jalan Perintis Kemerdekaan No 94 Jati Padang
TEL
08126776930
Homepage URL
eelbiomed@gmail.com
Sponsor or person
Institute
Indonesian Danone Institute Foundation
Institute
Department
Personal name
Funding Source
Organization
Andalas University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
The Ministry of Education in Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Department of Health Tanah Datar West Sumatra Indonesia
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://apjcn.nhri.org.tw/server/APJCN/26/1/index.php
Number of participants that the trial has enrolled
Results
There were improvements in linear growth, cognitive and motor development of children in the FS (p<0.05) and the FS+PS (p<0.01) groups compared to the CG. After six months of intervention, mean length increased to 6.86+2.08 cm and 6.66+2.41 cm for FS and FS+PS respectively (p<0.05). With the combination of food supplementation and psycho social stimulation (FS+PS), cognitive development increased to 21.4+12.2 points (effect size 0.56) (p<0.01) and motor development increased to 20.7+18.4 points (effect size 0.50) (p<0.001)
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 05 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 05 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 28 | Day |
Last modified on
| 2018 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038252
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
