Screening for Acute Malnutrition

NCT ID: NCT05284773

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2030-02-15
• Study Completion Date: 2035-03-10

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.

Conditions

Acute Malnutrition in Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Caretaker MUAC screening - training by health workers

Intervention Type: OTHER

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.

Caretaker MUAC screening - training by caregivers

Intervention Type: OTHER

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche en Sante de Nouna, Burkina Faso

OTHER_GOV

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Oldenbrug, ScD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kieran O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

17-24230

Identifier Type: -

Identifier Source: org_study_id