Screening for Acute Malnutrition

NCT05284773 | Withdrawn

• 1 other identifier: 17-24230
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (5)

• Sensitivity

  6 months

• Specificity

  6 months

• Cases referred

  6 months

• Mid-upper arm circumference (MUAC) at admission

  6 months

• Effectiveness of caregiver training

  6 months

Study Arms (2)

intervention + standard of care

EXPERIMENTAL

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; Other: Caretaker MUAC screening - training by caregivers

standard of care

NO INTERVENTION

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).

Interventions

Caretaker MUAC screening - training by health workers 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.

intervention + standard of care

Caretaker MUAC screening - training by caregivers 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.

intervention + standard of care

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Centre de Recherche en Sante de Nouna, Burkina Faso: collaborator

Study Officials

• Catherine Oldenbrug, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Kieran O'Brien, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will be randomized to intervention + standard of care; one group will be randomized to standard of care only

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 17, 2022
• Study Start (Estimated): February 15, 2030
• Primary Completion (Estimated): March 10, 2035
• Study Completion (Estimated): March 10, 2035
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share