Follow Up of Severely Malnourished Children (FUSAM)
- Conditions
- Severe Acute Malnutrition
- Interventions
- Other: NUTPSY treatmentOther: NUT treatment
- Registration Number
- NCT02672982
- Lead Sponsor
- Action Contre la Faim
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 427
- 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
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description new combined NUTPSY treatment NUTPSY treatment 2-month combined nutrition and psychosocial intervention standard NUT treatment NUT treatment 2-month of standard nutritional treatment only
- Primary Outcome Measures
Name Time Method Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire up to 11 months after inclusion The Ages and Stages Questionnaire (Squires et al, 1999), is a low-cost, easily administered, parent-report screening test of development in communication, motor, problem-solving and personal-social domains. The questionnaire has been adapted and used in low- and middle-income countries in Africa, Asia and Latin America, where it has demonstrated sensitivity to child nutritional status and psychosocial stimulation. While it is not a diagnostic test, it offers an opportunity to systematically obtain information about children's development with an instrument that does not require extensive training
- Secondary Outcome Measures
Name Time Method Mother-child interaction Up to 11 months after inclusion Action Contre la Faim's Mother-Child Interaction Grid will be used for assessing the quality of mother-child interactions and interpersonal sensitivity and responsiveness.
Child stimulation Up to 11 months after inclusion Family Care Indicators (FCI) (Frongillo et al, 2003) is used to assess the quality of child stimulation
Child Care Practices Up to 11 months after inclusion The quality of care practices is measured by assessing the level of knowledge and the practices. It comprises sub-thematics: care for women, pregnancy and delivery, care for the newborn, breastfeeding and feeding, access to resources for care, as well as child development and psychosocial care. The Child Care Knowledge \& Practices Questionnaire has been developped by Action Contre la Faim.
Maternal perinatal mental health Up to 11 months after inclusion The Edinburgh Post-natal Depression Scale (Cox et al, 1987) is a valuable and efficient way of identifying mothers at risk for "perinatal" depression.
Child nutritional status defined by Weight-For-Height Z-score Up to 11 months after inclusion Comparison of the mean Weight-For-Height Z-score
Child death (mortality rate) Up to 11 months after inclusion Follow-up of mortality rate
Perceived Social Support Up to 11 months after inclusion The Multidimensional Scale of Perceived Social Support (Zimet et al, 1988) measures perceived support from 3 sources: family, friends and significant others.
Maternal self-esteem Up to 11 months after inclusion The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.
Maternal mental health Up to 11 months after inclusion The WHO Self Reporting Questionnaire (SRQ-20) (WHO, 1994) assesses the frequency of depressive symptoms, anxiety, and psychosomatic complaints in the past month. The measure has been shown to be an accurate predictor of common mental disorder and has been successfully used in several studies in developing countries.
Child growth (height) Up to 11 months after inclusion Child growth measures change in height
Child nutritional status defined by Mid-Upper Arm Circumference (MUAC) Up to 11 months after inclusion Comparison of the mean MUAC adjusted to age, sex and height
Child nutritional status defined by height-for-Age Z score Up to 11 months after inclusion Comparison of the mean height-for-Age Z score
Child health status (morbidity rate) Up to 11 months after inclusion Follow-up of morbidity rate
Trial Locations
- Locations (1)
ACF, Nepal
🇳🇵Kathmandu, Nepal