<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036176</url>
  </required_header>
  <id_info>
    <org_study_id>EPFPS-2010</org_study_id>
    <nct_id>NCT03036176</nct_id>
  </id_info>
  <brief_title>Family Centered Developmental Intervention on Severely Acutely Malnourished Children</brief_title>
  <official_title>&quot;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&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jimma University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PXL University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children with severe acute malnutrition (SAM) are at serious risks that compromise their&#xD;
      growth and development. Studies have shown the benefits of psychosocial intervention in&#xD;
      mitigating the negative consequences of SAM. However, such intervention studies have targeted&#xD;
      the critical period in child development and thus focused on children under three years of&#xD;
      age. Dietary rehabilitation is usually included as part of the intervention package.&#xD;
      Moreover, these young children in such studies customarily obtain more care than older ones&#xD;
      and have access to breast milk, more frequent interaction with mother and other caregivers in&#xD;
      the family. Therefore, effects of psychosocial interventions targeting such age groups may be&#xD;
      different for older children. Much is not known if children older than three years of benefit&#xD;
      from similar interventions, and if family-based psychomotor/psychosocial intervention can&#xD;
      benefit SAM children in low income contexts such as Ethiopia where access to balanced diet&#xD;
      remains hardly possible. In Ethiopia, one of the poorest countries in the world, many&#xD;
      children are admitted to hospital for treatment due to SAM. The nutritional rehabilitation&#xD;
      unit at hospitals provide dietary treatment to the SAM children who are also treated for&#xD;
      related illnesses and complications. Once discharged from hospital, however, the SAM children&#xD;
      return to the same poor home environments with inadequate care and unbalanced diets. The main&#xD;
      objective of this study was to evaluate the effect of play-based family-centered&#xD;
      psychomotor/psychosocial stimulation on linear growth, nutritional status and developmental&#xD;
      outcomes of under-six SAM children in the Jimma Zone, south west Ethiopia. This was done by&#xD;
      randomly assigning the SAM children admitted to Jimma University's Specialized Referral&#xD;
      Teaching Hospital into control and intervention groups. Both groups were receiving the&#xD;
      routine medical and dietary treatment services. The intervention group additionally received&#xD;
      play-based psychomotor/psychosocial stimulation. Caregivers, supported by periodic visits&#xD;
      made to their homes, continued the simulation. Measurements were taken after six months of&#xD;
      home follow-up. It was hypothesized that the intervention would significantly improve some of&#xD;
      the developmental skills of these children, and that the effect may be age-dependent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Language outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test language outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Language outcome</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>Denver II-Jimma was used to test language outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Language outcome</measure>
    <time_frame>6 months after discharge from hospital</time_frame>
    <description>Denver II-Jimma was used to test language outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Personal-Social outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test Personal-social outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Personal-Social outcome</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>Denver II-Jimma was used to test Personal-social outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Personal-Social outcome</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>Denver II-Jimma was used to test Personal-social outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fine motor outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test Fine motor outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fine motor outcome</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>Denver II-Jimma was used to test Fine motor outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fine motor outcome</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>Denver II-Jimma was used to test Fine motor outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gross motor outcome</measure>
    <time_frame>baseline</time_frame>
    <description>Denver II-Jimma was used to test Gross motor outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gross motor outcome</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>Denver II-Jimma was used to test Gross motor outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gross motor outcome</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>Denver II-Jimma was used to test Gross motor outcome &amp; the total number of items successfully performed was counted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social-emotional outcome</measure>
    <time_frame>baseline</time_frame>
    <description>The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome &amp; a child's total behavior score was obtained by adding up scores on each of the items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social-emotional outcome</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome &amp; a child's total behavior score was obtained by adding up scores on each of the items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social-emotional outcome</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>The Ages and Stages questionnaire: Social emotional (ASQ:SE) was used to test Social emotional outcome &amp; a child's total behavior score was obtained by adding up scores on each of the items</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Linear growth</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear growth</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear growth</measure>
    <time_frame>6 months after discharge from hospital</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Weight -for-age)</measure>
    <time_frame>baseline</time_frame>
    <description>Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Weight -for-age)</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Weight -for-age)</measure>
    <time_frame>6 months after discharge from hospital</time_frame>
    <description>Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Weight for height/length)</measure>
    <time_frame>baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Weight for height/length)</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Weight for height/length)</measure>
    <time_frame>6 months after discharge from hospital</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Mid-upper-arm circumference)</measure>
    <time_frame>baseline</time_frame>
    <description>Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Mid-upper-arm circumference)</measure>
    <time_frame>at discharge from the hospital (on average at 2 weeks)</time_frame>
    <description>Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status (Mid-upper-arm circumference)</measure>
    <time_frame>6 months after discharge from hospital</time_frame>
    <description>Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">339</enrollment>
  <condition>Severly Acutely Malnourished Children</condition>
  <arm_group>
    <arm_group_label>SAM intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAM control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Play-based family centered stimulation</intervention_name>
    <description>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.</description>
    <arm_group_label>SAM intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>SAM control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        SAM children who were admitted for medical treatment and nutritional rehabilitation after&#xD;
        being confirmed by physicians to be severely acutely malnourished.&#xD;
&#xD;
        Inclusion criteria were:&#xD;
&#xD;
          1. children between 6 to 60 months of age&#xD;
&#xD;
          2. of Transition Phase i.e., Phase II (no medical complications) and, whose wasting was&#xD;
             severe (weight for height or weight for length less than 70% of the median on National&#xD;
             Centre for Health Statistics of USA; or&#xD;
&#xD;
          3. with a low mid upper arm circumference (MUAC), i.e., less than 110 mm with a length&#xD;
             greater than 65 cm; or,&#xD;
&#xD;
          4. having bilateral pitting edema,&#xD;
&#xD;
        Exclusion criteria were:&#xD;
&#xD;
        SAM children&#xD;
&#xD;
          1. who were completely deaf or blind,&#xD;
&#xD;
          2. who had complications that hinder mobility for play,&#xD;
&#xD;
          3. whose primary caregiver was not able to provide stimulation due to physical or mental&#xD;
             disability,&#xD;
&#xD;
          4. who were from far or inaccessible distance for follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>66 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marita Granitzer, prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasselt Univerity</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>prof. dr. Marita Granitzer</investigator_full_name>
    <investigator_title>prof.dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036176
org study id: EPFPS-2010
nct id: NCT03036176
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Language outcome
time frame: baseline
description: Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
measure: Language outcome
time frame: at discharge from the hospital (on average at 2 weeks)
description: Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
measure: Language outcome
time frame: 6 months after discharge from hospital
description: Denver II-Jimma was used to test language outcome & the total number of items successfully performed was counted.
measure: Personal-Social outcome
time frame: baseline
description: Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
measure: Personal-Social outcome
time frame: at discharge from the hospital (on average at 2 weeks)
description: Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
measure: Personal-Social outcome
time frame: 6 months after discharge
description: Denver II-Jimma was used to test Personal-social outcome & the total number of items successfully performed was counted.
measure: Fine motor outcome
time frame: baseline
description: Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
measure: Fine motor outcome
time frame: at discharge from the hospital (on average at 2 weeks)
description: Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
measure: Fine motor outcome
time frame: 6 months after discharge
description: Denver II-Jimma was used to test Fine motor outcome & the total number of items successfully performed was counted.
measure: Gross motor outcome
time frame: baseline
description: Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
measure: Gross motor outcome
time frame: at discharge from the hospital (on average at 2 weeks)
description: Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
measure: Gross motor outcome
time frame: 6 months after discharge
description: Denver II-Jimma was used to test Gross motor outcome & the total number of items successfully performed was counted.
measure: Social-emotional outcome
time frame: baseline
description: 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
measure: Social-emotional outcome
time frame: at discharge from the hospital (on average at 2 weeks)
description: 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
measure: Social-emotional outcome
time frame: 6 months after discharge
description: 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
measure: Linear growth
time frame: baseline
description: 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.
measure: Linear growth
time frame: at discharge from the hospital (on average at 2 weeks)
description: 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.
measure: Linear growth
time frame: 6 months after discharge from hospital
description: 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.
measure: Nutritional status (Weight -for-age)
time frame: baseline
description: Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
measure: Nutritional status (Weight -for-age)
time frame: at discharge from the hospital (on average at 2 weeks)
description: Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
measure: Nutritional status (Weight -for-age)
time frame: 6 months after discharge from hospital
description: Weight-for-age z score was used to determine nutritional status. A child's weight was measured by using a calibrated electronic weighing scale.
measure: Nutritional status (Weight for height/length)
time frame: baseline
description: 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.
measure: Nutritional status (Weight for height/length)
time frame: at discharge from the hospital (on average at 2 weeks)
description: 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.
measure: Nutritional status (Weight for height/length)
time frame: 6 months after discharge from hospital
description: 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.
measure: Nutritional status (Mid-upper-arm circumference)
time frame: baseline
description: Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
measure: Nutritional status (Mid-upper-arm circumference)
time frame: at discharge from the hospital (on average at 2 weeks)
description: Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
measure: Nutritional status (Mid-upper-arm circumference)
time frame: 6 months after discharge from hospital
description: Mid-upper-arm circumference z score was used to determine nutritional status. Mid Upper Arm Circumference (MUAC) was measured with MUAC tape.
arm group label: SAM intervention group
arm group type: Other
description: 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.
arm group label: SAM control Group
arm group type: Other
description: 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.
intervention type: Behavioral
intervention name: Play-based family centered stimulation
description: 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.
arm group label: SAM intervention group
intervention type: Other
intervention name: no intervention
description: 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.
arm group label: SAM control Group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 66 Months
healthy volunteers: No
last name: Marita Granitzer, prof. dr.
role: Principal Investigator
affiliation: Hasselt Univerity
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: prof. dr. Marita Granitzer
investigator title: prof.dr.
mesh term: Malnutrition