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Family Centered Developmental Intervention on Severely Acutely Malnourished Children

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ClinicalTrials.gov Identifier: NCT03036176
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborators:
Jimma University
University Ghent
PXL University College
Information provided by (Responsible Party):
prof. dr. Marita Granitzer, Hasselt University

Brief Summary:
Children with severe acute malnutrition (SAM) are at serious risks that compromise their growth and development. Studies have shown the benefits of psychosocial intervention in mitigating the negative consequences of SAM. However, such intervention studies have targeted the critical period in child development and thus focused on children under three years of age. Dietary rehabilitation is usually included as part of the intervention package. Moreover, these young children in such studies customarily obtain more care than older ones and have access to breast milk, more frequent interaction with mother and other caregivers in the family. Therefore, effects of psychosocial interventions targeting such age groups may be different for older children. Much is not known if children older than three years of benefit from similar interventions, and if family-based psychomotor/psychosocial intervention can benefit SAM children in low income contexts such as Ethiopia where access to balanced diet remains hardly possible. In Ethiopia, one of the poorest countries in the world, many children are admitted to hospital for treatment due to SAM. The nutritional rehabilitation unit at hospitals provide dietary treatment to the SAM children who are also treated for related illnesses and complications. Once discharged from hospital, however, the SAM children return to the same poor home environments with inadequate care and unbalanced diets. The main objective of this study was to evaluate the effect of play-based family-centered psychomotor/psychosocial stimulation on linear growth, nutritional status and developmental outcomes of under-six SAM children in the Jimma Zone, south west Ethiopia. This was done by randomly assigning the SAM children admitted to Jimma University's Specialized Referral Teaching Hospital into control and intervention groups. Both groups were receiving the routine medical and dietary treatment services. The intervention group additionally received play-based psychomotor/psychosocial stimulation. Caregivers, supported by periodic visits made to their homes, continued the simulation. Measurements were taken after six months of home follow-up. It was hypothesized that the intervention would significantly improve some of the developmental skills of these children, and that the effect may be age-dependent.

Condition or disease Intervention/treatment Phase
Severly Acutely Malnourished Children Behavioral: Play-based family centered stimulation Other: no intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: "Effects of a Play-based Family Centered Psychomotor/Psychosocial Stimulation on Recovery of Severely Malnourished Children of 6-60 Months of Age During Nutritional Rehabilitation in the Jimma Zone of Ethiopia"
Study Start Date : February 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SAM intervention group
Children in the intervention group received routine medical treatment and nutritional rehabilitation services in hospital; their primary caregivers were given basic orientations on child care, feeding and nutrition. Children attended play-based stimulation sessions in which trained nurses demonstrated caregivers on how to stimulate the SAM child using play materials and facilities at playroom and playground of the hospital. After discharge from hospital, they were followed up at home and visited three times over a period of six months. During the visits, new play materials were provided and caregivers were shown how to use them to stimulate the SAM child.
Behavioral: Play-based family centered stimulation
Children in the intervention group received routine medical treatment and nutritional rehabilitation services in hospital; their primary caregivers were given basic orientations on child care, feeding and nutrition. Children attended play-based stimulation sessions in which trained nurses demonstrated caregivers on how to stimulate the SAM child using play materials and facilities at playroom and playground of the hospital. After discharge from hospital, they were followed up at home and visited three times over a period of six months. During the visits, new play materials were provided and caregivers were shown how to use them to stimulate the SAM child.

SAM control Group
The control children received routine medical treatment and nutritional rehabilitation services in hospital. Though they had access to playground facilities neither the control children nor their caregivers had access to the playroom materials and the basic orientation on child care, feeding and stimulation.
Other: no intervention
On the other hand, the control SAM group did not receive the guided psychomotor/psychosocial stimulation services although they had access to the playground facilities. Both the intervention and the control groups received all the routine medical care and dietary rehabilitation services at the hospital.




Primary Outcome Measures :
  1. Language outcome [ Time Frame: baseline ]
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.

  2. Language outcome [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.

  3. Language outcome [ Time Frame: 6 months after discharge from hospital ]
    Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.

  4. Personal-Social outcome [ Time Frame: baseline ]
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.

  5. Personal-Social outcome [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.

  6. Personal-Social outcome [ Time Frame: 6 months after discharge ]
    Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.

  7. Fine motor outcome [ Time Frame: baseline ]
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.

  8. Fine motor outcome [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.

  9. Fine motor outcome [ Time Frame: 6 months after discharge ]
    Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.

  10. Gross motor outcome [ Time Frame: baseline ]
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.

  11. Gross motor outcome [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.

  12. Gross motor outcome [ Time Frame: 6 months after discharge ]
    Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.

  13. Social-emotional outcome [ Time Frame: baseline ]
    The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome & a child's total behavior score was obtained by adding up scores on each of the items

  14. Social-emotional outcome [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome & a child's total behavior score was obtained by adding up scores on each of the items

  15. Social-emotional outcome [ Time Frame: 6 months after discharge ]
    The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome & a child's total behavior score was obtained by adding up scores on each of the items


Secondary Outcome Measures :
  1. Linear growth [ Time Frame: baseline ]
    Height/length-for-age z score was used to determine linear growth. 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.

  2. Linear growth [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Height/length-for-age z score was used to determine linear growth. 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.

  3. Linear growth [ Time Frame: 6 months after discharge from hospital ]
    Height/length-for-age z score was used to determine linear growth. 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.

  4. Nutritional status (Weight -for-age) [ Time Frame: baseline ]
    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.

  5. Nutritional status (Weight -for-age) [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.

  6. Nutritional status (Weight -for-age) [ Time Frame: 6 months after discharge from hospital ]
    Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.

  7. Nutritional status (Weight for height/length) [ Time Frame: baseline ]
    Weight-for-height/length z score (for under five children) and body-max-index-for age z score (for children above five years) were used to determine nutritional status.

  8. Nutritional status (Weight for height/length) [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Weight-for-height/length z score (for under five children) and body-max-index-for age z score (for children above five years) were used to determine nutritional status.

  9. Nutritional status (Weight for height/length) [ Time Frame: 6 months after discharge from hospital ]
    Weight-for-height/length z score (for under five children) and body-max-index-for age z score (for children above five years) were used to determine nutritional status.

  10. Nutritional status (Mid-upper-arm circumference) [ Time Frame: baseline ]
    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.

  11. Nutritional status (Mid-upper-arm circumference) [ Time Frame: at discharge from the hospital (on average at 2 weeks) ]
    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.

  12. Nutritional status (Mid-upper-arm circumference) [ Time Frame: 6 months after discharge from hospital ]
    Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.



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Ages Eligible for Study:   6 Months to 66 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

SAM children who were admitted for medical treatment and nutritional rehabilitation after being confirmed by physicians to be severely acutely malnourished.

Inclusion criteria were:

  1. children between 6 to 60 months of age
  2. of Transition Phase i.e., Phase II (no medical complications) and, whose wasting was severe (weight for height or weight for length less than 70% of the median on National Centre for Health Statistics of USA; or
  3. with a low mid upper arm circumference (MUAC), i.e., less than 110 mm with a length greater than 65 cm; or,
  4. having bilateral pitting edema,

Exclusion criteria were:

SAM children

  1. who were completely deaf or blind,
  2. who had complications that hinder mobility for play,
  3. whose primary caregiver was not able to provide stimulation due to physical or mental disability,
  4. who were from far or inaccessible distance for follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036176


Sponsors and Collaborators
Hasselt University
Jimma University
University Ghent
PXL University College
Investigators
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Principal Investigator: Marita Granitzer, prof. dr. Hasselt Univerity

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Responsible Party: prof. dr. Marita Granitzer, prof.dr., Hasselt University
ClinicalTrials.gov Identifier: NCT03036176     History of Changes
Other Study ID Numbers: EPFPS-2010
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders