Screening for Acute Malnutrition

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Acute Malnutrition in Childhood

Treatments: Other: Caretaker MUAC screening - training by caregivers; Other: Caretaker MUAC screening - training by health workers

Study type: Interventional

Funder types: Other

Identifiers

NCT05284773

17-24230

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

intervention + standard of care

Experimental group

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.

Treatment:

Other: Caretaker MUAC screening - training by health workers

Other: Caretaker MUAC screening - training by caregivers

standard of care

No Intervention group

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).