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Follow Up of Severely Malnourished Children (FUSAM) (FUSAM)

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ClinicalTrials.gov Identifier: NCT02672982
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : July 25, 2017
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Severe Malnutrition Other: NUTPSY treatment Other: NUT treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 427 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.
Actual Study Start Date : December 8, 2014
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: new combined NUTPSY treatment
2-month combined nutrition and psychosocial intervention
Other: NUTPSY 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.

Active Comparator: standard NUT treatment
2-month of standard nutritional treatment only
Other: NUT treatment
Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672982


Locations
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Nepal
ACF, Nepal
Kathmandu, Nepal
Sponsors and Collaborators
Action Contre la Faim
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Cecile Bizouerne, PhD Action Contre la Faim
Additional Information:
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Responsible Party: Action Contre la Faim
ClinicalTrials.gov Identifier: NCT02672982    
Other Study ID Numbers: ACFInternational
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders