NCT03044548

Brief Summary

This is a cluster RCT in 6 health centres in Uganda, testing supportive supervision to improve health outcomes and quality of care of children with malnutrition

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

December 20, 2016

Last Update Submit

February 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cure rate

    Rate of cured among children diagnosed with acute malnutrition (SAM and MAM) Cured/discharged is defined as Weight-for-height \> -2 standard deviation (SD) from the mean based on the World Health Organisation (WHO) 2006 standards (11) on 2 consecutive visits and no oedema.

    12- 16 weeks

Secondary Outcomes (9)

  • Dead rate

    12- 16 weeks

  • Rate of Not cured

    12- 16 weeks

  • Rate of transferred to ITC (inpatient treatment center)

    12- 16 weeks

  • Rate of transferred to OTC (outpatient treatment center)

    12- 16 weeks

  • Rate of defaulted

    12- 16 weeks

  • +4 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Supportive supervision

Other: Supportive supervision

Control

NO INTERVENTION

No intervention

Interventions

" Supportive supervision". The specific characteristics of the supportive supervision as intended in this project are outlined below. Frequency: Biweekly in the first 3-5 months, than monthly. Duration: approximately 2 hours in each HC at each visit. Provider: local staff (nutritionist, DHO) trained in integrated management acute malnutrition (IMAM) guidelines and in methods of " supportive supervision". Receivers: nurses working at HC level with children with malnutrition. Reference guidelines: • Current National IMAM guidelines Attitude and philosophy: • Participatory peer-to-peer model based on the Plan - Do- Study- Act quality improvement (QI) Cycle .

Experimental

Eligibility Criteria

Age6 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 6 months-5 years
  • Diagnosis of SAM or MAM according to National criteria (10) SAM: weight-for-height \<- 3 standard deviation (SD) from the mean based on the WHO 2006 standards (11).
  • MAM: weight-for-height \<- 2 and \> -3 standard deviation (SD) from the mean based on the WHO 2006 growth reference standards .

You may not qualify if:

  • Not matching the above criteria for SAM and MAM
  • Refusal to participate/ consent
  • Unable to adhere to study follow up procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arua district

Arua, Uganda

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Marzia Lazzerini, PhD

    WHO CC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marzia Lazzerini, PhD

CONTACT

Humphrey Wanzira, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 20, 2016

First Posted

February 7, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations