Screening for Acute Malnutrition

Not Applicable

Not yet recruiting

• Conditions: Acute Malnutrition in Childhood
• Interventions: Other: Caretaker MUAC screening - training by health workers; Other: Caretaker MUAC screening - training by caregivers

• Registration Number: NCT05284773
• Lead Sponsor: University of California, San Francisco

Brief Summary

This project includes a pilot cluster-randomized trial of the efficacy of training caregivers to screen for acute malnutrition (AM) in children aged 6-59 months using mid-upper arm circumference (MUAC) in Burkina Faso. The pilot will be conducted to establish the feasibility of procedures and preliminary outcome data to inform the sample size calculations and design of a future longer-term, fully powered cluster-randomized trial. Forty communities enrolled in the Bill \& Melinda Gates Foundation-funded Child Health with Azithromycin Treatment (CHAT) trial will be randomly selected for this pilot and randomized to receive the caregiver training intervention or no additional intervention. All communities will continue to receive standard of care screening for AM according to national guidelines, which includes community-based screening for AM by community health workers using MUAC every 6 months. A baseline census will be conducted before randomization to enumerate the eligible population of caregivers and children 6-59 months old and measure MUAC. A final census with MUAC measurement will be conducted 6 months later (primary outcome). Data will be collected on all children presenting to the Centre de Santé et Promotion Sociale (CSPS) for malnutrition to track secondary outcomes.

During intervention training, we will also conduct a diagnostic accuracy study to evaluate the validity of caregiver screening by comparing the MUAC measurements of caregivers against the gold standard measurement of the experienced health personnel conducting the training. Also during training, intervention communities will be randomized to one of two training approaches: training by caregivers or training by health agents and adherence to the protocol during follow-up monitoring visits will be compared to determine effectiveness of training.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Study Start: 2030-02-15
• Primary Completion: 2035-03-10
• Study Completion: 2035-03-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6800

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention + standard of care	Caretaker MUAC screening - training by caregivers	Caretakers of children 6-59 months old living in communities assigned to the intervention arm will be trained to detect malnutrition using MUAC on their children weekly. Caretakers living in communities assigned to the intervention will also receive usual standard of care.
intervention + standard of care	Caretaker MUAC screening - training by health workers	Caretakers of children 6-59 months old living in communities assigned to the intervention arm will be trained to detect malnutrition using MUAC on their children weekly. Caretakers living in communities assigned to the intervention will also receive usual standard of care.

Primary Outcome Measures

Name	Time	Method
Community-level mean mid-upper arm circumference (MUAC)	6 months	Community-level mean MUAC in children 6-59 months of age as assessed during the final census after 6 months of intervention

Secondary Outcome Measures

Name	Time	Method
Sensitivity	6 months	Diagnostic accuracy study comparing caregiver measurements to the gold standard measurement from study personnel will include sensitivity as an outcome measure, defined as the number of true positives divided by the total number of cases of global acute malnutrition (MUAC \< 125 mm)
Cases referred	6 months	Number of cases of AM referred to the CSPS during the study period as collected at the CSPS
Effectiveness of caregiver training	6 months	Adherence to protocol in the communities with caretakers training compared to health workers training as measured by caregiver survey and supervisor monitoring checklist. Relevant items from each data collection source will be summarized into a single summary score.
Mid-upper arm circumference (MUAC) at admission	6 months	MUAC among children 6-59 months of age at admission to CSPS nutritional programs during the study period as routinely collected at the CSPS
Specificity	6 months	Diagnostic accuracy study comparing caregiver measurements to the gold standard measurement from study personnel will include specificity as an outcome measure, defined as the number of true negatives divided by the total number of children without global acute malnutrition (MUAC \< 125 mm)