Follow Up of Severely Malnourished Children (FUSAM)

Severe Acute Malnutrition Clinical Trial

— FUSAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672982
• Other study ID #: ACFInternational
• Status: Completed
• Phase: N/A
• Start date: December 8, 2014
• Est. completion date: January 31, 2017

Study information

• Verified date: March 2022
• Source: Action Contre la Faim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

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,

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

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

Locations

Country	Name	City	State
Nepal	ACF, Nepal	Kathmandu

Sponsors (2)

Lead Sponsor	Collaborator
Action Contre la Faim	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire	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	up to 11 months after inclusion
Secondary	Child Care Practices	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.	Up to 11 months after inclusion
Secondary	Mother-child interaction	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.	Up to 11 months after inclusion
Secondary	Child stimulation	Family Care Indicators (FCI) (Frongillo et al, 2003) is used to assess the quality of child stimulation	Up to 11 months after inclusion
Secondary	Maternal perinatal mental health	The Edinburgh Post-natal Depression Scale (Cox et al, 1987) is a valuable and efficient way of identifying mothers at risk for "perinatal" depression.	Up to 11 months after inclusion
Secondary	Perceived Social Support	The Multidimensional Scale of Perceived Social Support (Zimet et al, 1988) measures perceived support from 3 sources: family, friends and significant others.	Up to 11 months after inclusion
Secondary	Maternal self-esteem	The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.	Up to 11 months after inclusion
Secondary	Maternal mental health	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.	Up to 11 months after inclusion
Secondary	Child growth (height)	Child growth measures change in height	Up to 11 months after inclusion
Secondary	Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)	Comparison of the mean MUAC adjusted to age, sex and height	Up to 11 months after inclusion
Secondary	Child nutritional status defined by Weight-For-Height Z-score	Comparison of the mean Weight-For-Height Z-score	Up to 11 months after inclusion
Secondary	Child nutritional status defined by height-for-Age Z score	Comparison of the mean height-for-Age Z score	Up to 11 months after inclusion
Secondary	Child health status (morbidity rate)	Follow-up of morbidity rate	Up to 11 months after inclusion
Secondary	Child death (mortality rate)	Follow-up of mortality rate	Up to 11 months after inclusion

External Links

•   Media link from the first communication event of the FUSAM project in Nepal and steering committee meeting
•   Oral presentation at the ACF International conference in Nepal, June 2017