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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033546
Receipt No. R000038252
Official scientific title of the study 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

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Basic information
Official scientific title of the study Effect of Psychosocial Stimulation on Improving Home Environment and Infant Development in West Sumatera, Indonesia
Title of the study (Brief title) 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 Dr.Helmizar
Organization Andalas University Padang
Division name Department of Nutrition Faculty of Public Health
Address Jalan Perintis Kemerdekaan No 94 Jati Padang
TEL 08126776930
Email eelbiomed@gmail.com

Public contact
Name of contact person Dr.Helmizar
Organization Andalas University Padang
Division name Department of Nutrition Faculty of Public Health
Address Jalan Perintis Kemerdekaan No 94 Jati Padang
TEL 08126776930
Homepage URL
Email eelbiomed@gmail.com

Sponsor
Institute Indonesian Danone Institute Foundation
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results http://apjcn.nhri.org.tw/server/APJCN/26/1/index.php
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)
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
URL(English) https://upload.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
Registered date File name


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