Child MalnutritionRAINCT02988180
Intervention on Development and Growth at Children in Poverty
A study testing basic services and the play-based developmental stimulation in people with Child Malnutrition, run by Hasselt University at 2 sites in 2 countries.
Trial summary
Children in extreme poverty lack adequate care and face increased health risks. The earlier poverty strikes in the developmental process, the more deleterious and long-lasting its effects. There is, however, growing evidence that early interventions can prevent the negative consequences. Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- basic services and the play-based developmental stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with observable physical disabilities which hinders mobility;
- Children with severe mental retardation;
- Children with discernable hearing and visual impairments.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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)
Children in extreme poverty lack adequate care and face increased health risks. The earlier poverty strikes in the developmental process, the more deleterious and long-lasting its effects. There is, however, growing evidence that early interventions can prevent the negative consequences. Such interventions are effective, particularly when they are of high quality, organized at home and parents are involved. Recently, baseline assessment of developmental and nutritional status of SOS children and children in extreme poverty in Jimma region of South-West Ethiopia revealed that these children have developmental problems in language, motor, social-emotional skills and nutritional status. The impact of play-oriented stimulation activities integrated into the existing SOS basic program, on developmental outcomes, has never been investigated in this context. The main objective of the study is, therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS program on the developmental outcomes of children living with foster families. This was done by comparing the intervention children with their age-matched children (control), not receiving the stimulation package. It was hypothesized that this package would significantly improve the developmental skills of these children.
- Conditions
- Child Malnutrition
- Being tested
- basic services, the play-based developmental stimulation
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basic servicesOther
The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.
the play-based developmental stimulationOther
Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Other | Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services. Receives: Other: basic services; Other: the play-based developmental stimulation |
| control group | Other | The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation. Receives: Other: basic services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal-social outcome
Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
Measured: baseline
Personal-social outcome
Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
Measured: month 3
Personal-social outcome
Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
Measured: month 6
fine motor outcome
Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
Measured: baseline
fine motor outcome
Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
Measured: 3 months
fine motor outcome
Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
Measured: 6 months
gross motor outcome
Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
Measured: baseline
gross motor outcome
Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
Measured: 3 months
gross motor outcome
Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
Measured: 6 months
language outcome
Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
Measured: baseline
language outcome
Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
Measured: 3 months
language outcoome
Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
Measured: 6 months
Social-emotional outcome
Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
Measured: baseline
Social-emotional outcome
Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
Measured: 3 months
Social-emotional outcome
Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
Measured: 6 months
Secondary outcomes (6)
weight
A child's weight was measured by using a calibrated electronic weighing scale.
Measured: baseline
weight
A child's weight was measured by using a calibrated electronic weighing scale.
Measured: 3 months
weight
A child's weight was measured by using a calibrated electronic weighing scale.
Measured: 6 months
Height
For children under two years of age, a length measuring board on a flat table was used. For children under two years of age, a length measuring board on a flat table was used. The height of a child above two years of age was measured by using a portable stadiometer.
Measured: baseline
Height
For children under two years of age, a length measuring board on a flat table was used. The height of a child above two years of age was measured by using a portable stadiometer.
Measured: 3 months
Height
For children under two years of age, a length measuring board on a flat table was used. The height of a child above two years of age was measured by using a portable stadiometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University, VLIR-UOS (Vlaamse Interuniversitaire Raad).
- Responsible party
- Principal investigator, prof. dr. Marita Granitzer, Hasselt University
- Investigators
- Teklu Gemechu Abessa, Study chair, Jimma UniversityMekitie Wondafrash, nutritionist, Study chair, Jimma UniversityPatrick Kolsteren, prof.dr, Study chair, University GhentBerhanu Nigussie Worku, psychologist, Study chair, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988180
- Sponsor's protocol ID
- DGSC-2015
- Acronym
- RAI
- Status last verified
- Dec 2016
- First submitted
- 17 Nov 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Worku BN, Abessa TG, Wondafrash M, Lemmens J, Valy J, Bruckers L, Kolsteren P, Granitzer M. Effects of home-based play-assisted stimulation on developmental performances of children living in extreme poverty: a randomized single-blind controlled trial. BMC Pediatr. 2018 Feb 5;18(1):29. doi: 10.1186/s12887-018-1023-0.
PubMed 29402258
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02988180
- Acronym / sponsor ID
- RAI / DGSC-2015
- Conditions
- Child Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jimma University, VLIR-UOS (Vlaamse Interuniversitaire Raad).
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children in extreme poverty lack adequate care and face increased health risks. The earlier poverty strikes in the developmental process, the more deleterious and long-lasting its effects. There is, however, growing evidence that early interventions can prevent the negative consequences. Such interventions are effective, particularly when they are of high quality, organized at home and parents are involved. Recently, baseline assessment of developmental and nutritional status of SOS children and children in extreme poverty in Jimma region of South-West Ethiopia revealed that these children have developmental problems in language, motor, social-emotional skills and nutritional status. The impact of play-oriented stimulation activities integrated into the existing SOS basic program, on developmental outcomes, has never been investigated in this context. The main objective of the study is, therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS program on the developmental outcomes of children living with foster families. This was done by comparing the intervention children with their age-matched children (control), not receiving the stimulation package. It was hypothesized that this package would significantly improve the developmental skills of these children.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Other | Other: basic services, Other: the play-based developmental stimulationChildren in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services. |
| control group | Other | Other: basic servicesThe age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation. |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with observable physical disabilities which hinders mobility;
- Children with severe mental retardation;
- Children with discernable hearing and visual impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| basic servicesThe age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation. | Other | control group, intervention group |
| the play-based developmental stimulationChildren in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services. | Other | intervention group |
Primary outcome
Personal-social outcome
Time frame: baseline
Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
Personal-social outcome
Time frame: month 3
Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
Personal-social outcome
Time frame: month 6
Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis
fine motor outcome
Time frame: baseline
Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
fine motor outcome
Time frame: 3 months
Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
fine motor outcome
Time frame: 6 months
Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis
gross motor outcome
Time frame: baseline
Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
gross motor outcome
Time frame: 3 months
Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
gross motor outcome
Time frame: 6 months
Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis
language outcome
Time frame: baseline
Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
language outcome
Time frame: 3 months
Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
language outcoome
Time frame: 6 months
Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis
Social-emotional outcome
Time frame: baseline
Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
Social-emotional outcome
Time frame: 3 months
Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
Social-emotional outcome
Time frame: 6 months
Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children
6 secondary outcomes
weight
Time frame: baseline
weight
Time frame: 3 months
weight
Time frame: 6 months
Height
Time frame: baseline
Height
Time frame: 3 months
Height
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Derived from this study: PubMed 29402258Worku BN, Abessa TG, Wondafrash M, Lemmens J, Valy J, Bruckers L, Kolsteren P, Granitzer M. Effects of home-based play-assisted stimulation on developmental performances of children living in extreme poverty: a randomized single-blind controlled trial. BMC Pediatr. 2018 Feb 5;18(1):29. doi: 10.1186/s12887-018-1023-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teklu Gemechu Abessa study chair
Jimma University
Mekitie Wondafrash, nutritionist study chair
Jimma University
Patrick Kolsteren, prof.dr study chair
University Ghent
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing basic services and the play-based developmental stimulation in people with Child Malnutrition, run by Hasselt University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal-social outcome (time frame: baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.