Clinical trial NCT02672982: Follow Up of Severely Malnourished Children (FUSAM)
Official title: Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Keywords: Severe acute malnutrition
Psychosocial intervention
Child
Stimulation
CMAM
Nepal
Lead sponsor: Action Contre la Faim
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2016-02-03
Enrollment: 427
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal.

Detailed description: In Nepal, the majority of SAM children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. The two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. The proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. It includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. Adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.

Eligibility criteria: Inclusion Criteria:

* Age: 6-23 months
* 2 sexes
* Diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (OTPs), supported by Action Contre la Faim in Saptari district
* Weight-for-height (WH) \<-3 Standard Deviation compared to the WHO reference and/or MUAC \<115 mm
* And / or nutritional oedema moderate (+ or + +)
* And successful test of appetite
* And no medical complications
* New cases
* Presence of mother / father or legal guardian aged \> 18 years.
* Understanding of the consent and information letter
* Follow-up possible

Exclusion Criteria:

* Age \<6 months or\> 24 months
* Moderate Acute Malnutrition
* Severe Acute Malnutrition complicated
* Weight for height \<-3 Standard Deviation compared to the WHO reference and / or MUAC \<115mm but failure to test appetite OR medical complications OR severe oedema + + + OR kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe).
* Relapse or if already registered in the past two months;
* Any child with developmental anomalies, known chronic illnesses like epilepsy, twins and multiple births, parents not consenting,

Primary outcomes:
measure: Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire
timeFrame: up to 11 months after inclusion
Secondary outcomes:
measure: Child Care Practices
timeFrame: Up to 11 months after inclusion
measure: Mother-child interaction
timeFrame: Up to 11 months after inclusion
measure: Child stimulation
timeFrame: Up to 11 months after inclusion
measure: Maternal perinatal mental health
timeFrame: Up to 11 months after inclusion
measure: Perceived Social Support
timeFrame: Up to 11 months after inclusion
measure: Maternal self-esteem
timeFrame: Up to 11 months after inclusion
measure: Maternal mental health
timeFrame: Up to 11 months after inclusion
measure: Child growth (height)
timeFrame: Up to 11 months after inclusion
measure: Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)
timeFrame: Up to 11 months after inclusion
measure: Child nutritional status defined by Weight-For-Height Z-score
timeFrame: Up to 11 months after inclusion
measure: Child nutritional status defined by height-for-Age Z score
timeFrame: Up to 11 months after inclusion
measure: Child health status (morbidity rate)
timeFrame: Up to 11 months after inclusion
measure: Child death (mortality rate)
timeFrame: Up to 11 months after inclusion
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: ACF, Nepal
Study officials:
affiliation: Action Contre la Faim
name: Cecile Bizouerne, PhD
role: PRINCIPAL_INVESTIGATOR
References: