NCT02672982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

January 13, 2015

Last Update Submit

March 11, 2022

Conditions

Severe Acute Malnutrition

Keywords

Severe acute malnutritionPsychosocial interventionChildStimulationCMAMNepal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Child Care Practices

    Up to 11 months after inclusion

  • Mother-child interaction

    Up to 11 months after inclusion

  • Child stimulation

    Up to 11 months after inclusion

  • Maternal perinatal mental health

    Up to 11 months after inclusion

  • Perceived Social Support

    Up to 11 months after inclusion

  • +8 more secondary outcomes

Study Arms (2)

new combined NUTPSY treatment

EXPERIMENTAL

2-month combined nutrition and psychosocial intervention

Other: NUTPSY treatment

standard NUT treatment

ACTIVE COMPARATOR

2-month of standard nutritional treatment only

Other: NUT treatment

Interventions

NUTPSY treatmentOTHER

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.

new combined NUTPSY treatment
NUT treatmentOTHER

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

standard NUT treatment

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6-23 months
  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACF, Nepal

Kathmandu, Nepal

Location

Related Links

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Cecile Bizouerne, PhD

    Action Contre la Faim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 3, 2016

Study Start

December 8, 2014

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)