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Follow Up of Severely Malnourished Children (FUSAM)

Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02672982
Acronym
FUSAM
Enrollment
427
Registered
2016-02-03
Start date
2014-12-08
Completion date
2017-01-31
Last updated
2022-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Malnutrition

Keywords

Severe acute malnutrition, Psychosocial intervention, Child, Stimulation, CMAM, Nepal

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.

Interventions

OTHERNUTPSY treatment

The psychosocial component of the new combined treatment involves seven weekly counselling sessions with mothers focused on feeding, emotional attachment, stages of child development, stimulation, emotional responsiveness and interaction, and on concerns/strategies of child care and parenting.

OTHERNUT treatment

Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
Action Contre la Faim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaireup to 11 months after inclusionThe 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

MeasureTime frameDescription
Mother-child interactionUp to 11 months after inclusionAction 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 stimulationUp to 11 months after inclusionFamily Care Indicators (FCI) (Frongillo et al, 2003) is used to assess the quality of child stimulation
Maternal perinatal mental healthUp to 11 months after inclusionThe Edinburgh Post-natal Depression Scale (Cox et al, 1987) is a valuable and efficient way of identifying mothers at risk for perinatal depression.
Perceived Social SupportUp to 11 months after inclusionThe Multidimensional Scale of Perceived Social Support (Zimet et al, 1988) measures perceived support from 3 sources: family, friends and significant others.
Maternal self-esteemUp to 11 months after inclusionThe Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.
Maternal mental healthUp to 11 months after inclusionThe 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 Care PracticesUp to 11 months after inclusionThe 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.
Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)Up to 11 months after inclusionComparison of the mean MUAC adjusted to age, sex and height
Child nutritional status defined by Weight-For-Height Z-scoreUp to 11 months after inclusionComparison of the mean Weight-For-Height Z-score
Child nutritional status defined by height-for-Age Z scoreUp to 11 months after inclusionComparison of the mean height-for-Age Z score
Child health status (morbidity rate)Up to 11 months after inclusionFollow-up of morbidity rate
Child death (mortality rate)Up to 11 months after inclusionFollow-up of mortality rate
Child growth (height)Up to 11 months after inclusionChild growth measures change in height

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026