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Screening for Acute Malnutrition

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ClinicalTrials.gov Identifier: NCT05284773
Recruitment Status : Not yet recruiting
First Posted : March 17, 2022
Last Update Posted : March 17, 2022
Sponsor:
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acute Malnutrition in Childhood Other: Caretaker MUAC screening - training by health workers Other: Caretaker MUAC screening - training by caregivers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group will be randomized to intervention + standard of care; one group will be randomized to standard of care only
Masking: Single (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.
Primary Purpose: Prevention
Official Title: Screening for Acute Malnutrition: a Cluster Randomized Trial Comparing Caregivers to Community Health Workers in Burkina Faso
Estimated Study Start Date : February 15, 2023
Estimated Primary Completion Date : March 10, 2025
Estimated Study Completion Date : March 10, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention + standard of care
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.
Other: Caretaker MUAC screening - training by health workers
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.

Other: Caretaker MUAC screening - training by caregivers
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.

No Intervention: 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).



Primary Outcome Measures :
  1. Community-level mean mid-upper arm circumference (MUAC) [ Time Frame: 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 :
  1. Sensitivity [ Time Frame: 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)

  2. Specificity [ Time Frame: 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)

  3. Cases referred [ Time Frame: 6 months ]
    Number of cases of AM referred to the CSPS during the study period as collected at the CSPS

  4. Mid-upper arm circumference (MUAC) at admission [ Time Frame: 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

  5. Effectiveness of caregiver training [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05284773


Contacts
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Contact: Kieran O'Brien, PhD 4155142163 kieran.obrien@ucsf.edu
Contact: Elodie Lebas, RN 5104232245 elodie.lebas@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Centre de Recherche en Sante de Nouna, Burkina Faso
Investigators
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Principal Investigator: Catherine Oldenbrug, ScD University of California, San Francisco
Principal Investigator: Kieran O'Brien, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05284773    
Other Study ID Numbers: 17-24230
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders