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Completed

NCT Number: NCT02672982

Follow Up of Severely Malnourished Children (FUSAM)

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.

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Key information

Age range

6 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ACF, Nepal

Kathmandu, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

NUTPSY treatment

Other

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.

NUT treatment

Other

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

Primary outcomes

  1. Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire

    Time frame: 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 outcomes

  1. Child Care Practices

    Time frame: 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.

  2. Mother-child interaction

    Time frame: 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.

  3. Child stimulation

    Time frame: Up to 11 months after inclusion

    Family Care Indicators (FCI) (Frongillo et al, 2003) is used to assess the quality of child stimulation

  4. Maternal perinatal mental health

    Time frame: 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.

  5. Perceived Social Support

    Time frame: 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.

  6. Maternal self-esteem

    Time frame: Up to 11 months after inclusion

    The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.

  7. Maternal mental health

    Time frame: 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.

  8. Child growth (height)

    Time frame: Up to 11 months after inclusion

    Child growth measures change in height

  9. Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)

    Time frame: Up to 11 months after inclusion

    Comparison of the mean MUAC adjusted to age, sex and height

  10. Child nutritional status defined by Weight-For-Height Z-score

    Time frame: Up to 11 months after inclusion

    Comparison of the mean Weight-For-Height Z-score

  11. Child nutritional status defined by height-for-Age Z score

    Time frame: Up to 11 months after inclusion

    Comparison of the mean height-for-Age Z score

  12. Child health status (morbidity rate)

    Time frame: Up to 11 months after inclusion

    Follow-up of morbidity rate

  13. Child death (mortality rate)

    Time frame: Up to 11 months after inclusion

    Follow-up of mortality rate

Sponsors and collaborators

Lead sponsor

Action Contre la Faim

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study title

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

Acronym: FUSAM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2016
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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