Screening for Acute Malnutrition

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05284773

Collaborator

Centre de Recherche en Sante de Nouna, Burkina Faso (Other)

6,800

Enrollment

Arms

24.8

Anticipated Duration (Months)

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 onlyOne 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

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Mar 10, 2025

Anticipated Study Completion Date :

Mar 10, 2025

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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)
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)
Cases referred [6 months]
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 [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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, San Francisco
Centre de Recherche en Sante de Nouna, Burkina Faso

Investigators

Principal Investigator: Catherine Oldenbrug, ScD, University of California, San Francisco
Principal Investigator: Kieran O'Brien, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05284773

Other Study ID Numbers:

17-24230

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Mar 17, 2022