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Register:	ClinicalTrials.gov
Last refreshed on:	9 January 2017
Main ID:	NCT02988180
Date of registration:	17/11/2016
Prospective Registration:	No
Primary sponsor:	Hasselt University
Public title:	Intervention on Development and Growth at Children in Poverty RAI
Scientific title:	Developmental and Growth Status of Children (6-60 Months of Age) in Extreme Poverty in Jimma Town of Ethiopia: Effects of Developmental Stimulation - RAI (Risk Analysis and Intervention)
Date of first enrolment:	October 2015
Target sample size:	78
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02988180
Study type:	Interventional
Study design:	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
Phase:	N/A

Countries of recruitment
Belgium	Ethiopia

Contacts

Name:	Mekitie Wondafrash, nutritionist
Address:
Telephone:
Email:
Affiliation:	Jimma University

Name:	Berhanu Nigussie Worku, psychologist
Address:
Telephone:
Email:
Affiliation:	Jimma University

Name:	Teklu Gemechu Abessa
Address:
Telephone:
Email:
Affiliation:	Jimma University

Name:	Patrick Kolsteren, prof.dr
Address:
Telephone:
Email:
Affiliation:	University Ghent

Key inclusion & exclusion criteria

Inclusion Criteria:

- Children who were selected by the SOS children's village as lacking parental care and
receive basic services;

- Children living in Jimma town;

- Children from 3 months to 59 months of age.

Exclusion Criteria:

- Children with observable physical disabilities which hinders mobility;

- Children with severe mental retardation;

- Children with discernable hearing and visual impairments.

Age minimum: 3 Months
Age maximum: 59 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Child Malnutrition

Intervention(s)

Other: basic services

Other: the play-based developmental stimulation

Primary Outcome(s)

gross motor outcome [Time Frame: baseline]

language outcome [Time Frame: baseline]

fine motor outcome [Time Frame: 6 months]

Personal-social outcome [Time Frame: month 3]

gross motor outcome [Time Frame: 3 months]

language outcome [Time Frame: 3 months]

Social-emotional outcome [Time Frame: 6 months]

Personal-social outcome [Time Frame: month 6]

Social-emotional outcome [Time Frame: baseline]

fine motor outcome [Time Frame: baseline]

language outcoome [Time Frame: 6 months]

fine motor outcome [Time Frame: 3 months]

Social-emotional outcome [Time Frame: 3 months]

Personal-social outcome [Time Frame: baseline]

gross motor outcome [Time Frame: 6 months]

Secondary Outcome(s)

Height [Time Frame: baseline]

weight [Time Frame: baseline]

Height [Time Frame: 3 months]

Height [Time Frame: 6 months]

weight [Time Frame: 3 months]

weight [Time Frame: 6 months]

Secondary ID(s)

DGSC-2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jimma University

VLIR-UOS (Vlaamse Interuniversitaire Raad).

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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