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Screening for Acute Malnutrition

Primary Purpose

Acute Malnutrition in Childhood

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Caretaker MUAC screening - training by health workers
Caretaker MUAC screening - training by caregivers
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Malnutrition in Childhood

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Cluster level:

  • Enrollment in the CHAT trial
  • Location outside of the Health and Demographic Surveillance System (HDSS)
  • Population size < 2000 people
  • Verbal consent of the village leader

Individual level:

  • Residence in a village participating in the CHAT trial
  • Caregiver or guardian of children aged 6-59 months (for intervention training)
  • Age 6-59 months (for MUAC screening and some outcome assessments)
  • Verbal consent from caregiver or guardian

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention + standard of care

    standard of care

    Arm Description

    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.

    Caretakers of children 6-59 months living in communities assigned to the standard of care arm will receive usual acute malnutrition screening. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the Centre de Sante et Promotion Sociale (CSPS).

    Outcomes

    Primary Outcome Measures

    Community-level mean mid-upper arm circumference (MUAC)
    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

    Sensitivity
    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)
    Specificity
    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)
    Cases referred
    Number of cases of AM referred to the CSPS during the study period as collected at the CSPS
    Mid-upper arm circumference (MUAC) at admission
    MUAC among children 6-59 months of age at admission to CSPS nutritional programs during the study period as routinely collected at the CSPS
    Effectiveness of caregiver training
    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.

    Full Information

    First Posted
    February 25, 2022
    Last Updated
    May 8, 2023
    Sponsor
    University of California, San Francisco
    Collaborators
    Centre de Recherche en Sante de Nouna, Burkina Faso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05284773
    Brief Title
    Screening for Acute Malnutrition
    Official Title
    Screening for Acute Malnutrition: a Cluster Randomized Trial Comparing Caregivers to Community Health Workers in Burkina Faso
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2030 (Anticipated)
    Primary Completion Date
    March 10, 2035 (Anticipated)
    Study Completion Date
    March 10, 2035 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco
    Collaborators
    Centre de Recherche en Sante de Nouna, Burkina Faso

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Malnutrition in Childhood

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One group will be randomized to intervention + standard of care; one group will be randomized to standard of care only
    Masking
    Outcomes Assessor
    Masking Description
    Masking of participants and intervention administrators will not be possible due to the nature of the intervention. Primary outcome assessors will be masked to allocation.
    Allocation
    Randomized
    Enrollment
    6800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention + standard of care
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    standard of care
    Arm Type
    No Intervention
    Arm Description
    Caretakers of children 6-59 months living in communities assigned to the standard of care arm will receive usual acute malnutrition screening. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the Centre de Sante et Promotion Sociale (CSPS).
    Intervention Type
    Other
    Intervention Name(s)
    Caretaker MUAC screening - training by health workers
    Intervention Description
    Study personnel will train caregivers to conduct weekly AM screening using the color-coded MUAC tape. AM screening will involve identifying the midpoint of the child's right arm, wrapping the tape around the mid-point, inserting one end of the tape through the slit at the other end, pulling the tape secure, and reading the measurement based on the color bands. Caregivers will be trained to refer children with yellow or red readings to the nearest CSPS and will be provided with a referral slip to do so. Caregivers will be informed of the signs, symptoms, and consequences of malnutrition as well as the available nutritional programs. Study personnel will conduct monthly supervision visits including brief refresher trainings. In all study communities, standard of care screening for AM will continue. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the CSPS.
    Intervention Type
    Other
    Intervention Name(s)
    Caretaker MUAC screening - training by caregivers
    Intervention Description
    Study personnel will train a group of caregivers to perform AM training of all caregivers living in their communities. they will instruct caregivers to conduct weekly AM screening. Training will include the same information as the communities receiving training by Health workers: MUAC training and how to interpret MUAC as well as key concepts of malnutrition. Caregivers will be trained to refer children with yellow or red readings to the nearest CSPS and will be. In all study communities, standard of care screening for AM will continue. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the CSPS.
    Primary Outcome Measure Information:
    Title
    Community-level mean mid-upper arm circumference (MUAC)
    Description
    Community-level mean MUAC in children 6-59 months of age as assessed during the final census after 6 months of intervention
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Sensitivity
    Description
    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)
    Time Frame
    6 months
    Title
    Specificity
    Description
    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)
    Time Frame
    6 months
    Title
    Cases referred
    Description
    Number of cases of AM referred to the CSPS during the study period as collected at the CSPS
    Time Frame
    6 months
    Title
    Mid-upper arm circumference (MUAC) at admission
    Description
    MUAC among children 6-59 months of age at admission to CSPS nutritional programs during the study period as routinely collected at the CSPS
    Time Frame
    6 months
    Title
    Effectiveness of caregiver training
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Cluster level: Enrollment in the CHAT trial Location outside of the Health and Demographic Surveillance System (HDSS) Population size < 2000 people Verbal consent of the village leader Individual level: Residence in a village participating in the CHAT trial Caregiver or guardian of children aged 6-59 months (for intervention training) Age 6-59 months (for MUAC screening and some outcome assessments) Verbal consent from caregiver or guardian
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kieran O'Brien, PhD
    Phone
    4155142163
    Email
    kieran.obrien@ucsf.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elodie Lebas, RN
    Phone
    5104232245
    Email
    elodie.lebas@ucsf.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine Oldenbrug, ScD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kieran O'Brien, PhD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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