Screening for Acute Malnutrition
NCT05284773 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-09-19
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
Interventions
- 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.
Sponsors & Collaborators
-
Centre de Recherche en Sante de Nouna, Burkina Faso
collaborator OTHER_GOV -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Catherine Oldenbrug, ScD · University of California, San Francisco
-
Kieran O'Brien, PhD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 59 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2030-02-15
- Primary Completion
- 2035-03-10
- Completion
- 2035-03-10
More Related Trials
-
Dietary Rehabilitation in Severely Acutely Malnourished Children
NCT05009823 ·Status: COMPLETED
-
Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)
NCT06038071 ·Status: RECRUITING ·Phase: NA
-
Improving the Quality of Care for Children With Acute Malnutrition in Uganda
NCT03044548 ·Status: UNKNOWN ·Phase: NA
-
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
NCT06792370 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.
NCT05571280 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition
NCT05586139 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso
NCT02071563 ·Status: COMPLETED ·Phase: NA
-
Developing Low-Cost Universal Malnutrition Screening for Low Income Countries - the MAMMS Trial
NCT03967015 ·Status: UNKNOWN ·Phase: NA
-
Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
NCT03474276 ·Status: COMPLETED ·Phase: PHASE3
-
Integrated Research on Acute Malnutrition in Mali (IRAM-MALI)
NCT04872088 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition
NCT01154595 ·Status: COMPLETED ·Phase: PHASE4
-
Cluster Randomized, Parallel-group, Prospective, Follow-up Effectiveness Study in Kenyan Children 6-35 Months
NCT03448484 ·Status: COMPLETED ·Phase: NA
-
Integrated Research on Acute Malnutrition in Chad
NCT04867694 ·Status: COMPLETED ·Phase: NA
-
Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo
NCT03751475 ·Status: COMPLETED ·Phase: NA
-
MAM'Out Project - Evaluation of Multiannual and Seasonal Cash Transfers to Prevent Acute Malnutrition
NCT01866124 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM
NCT05020847 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor.
NCT05015257 ·Status: COMPLETED ·Phase: NA
-
Adolescent Nutrition in Girls in Burkina Faso and Ethiopia
NCT06444555 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
NCT06382857 ·Status: RECRUITING ·Phase: NA
-
Nutritional Status and Bouillon Use in Northern Ghana
NCT04632771 ·Status: COMPLETED
-
Preventing Infant Malnutrition With Early Supplementation
NCT04704076 ·Status: COMPLETED ·Phase: NA
-
The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study
NCT02323815 ·Status: COMPLETED ·Phase: PHASE4
-
Joint Infant and Young Child Nutrition Program and Malnutrition Prevention
NCT02136966 ·Status: COMPLETED ·Phase: NA
-
Management of Children With Moderate Acute Malnutrition in Mali
NCT01015950 ·Status: COMPLETED ·Phase: NA
-
Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition
NCT03146897 ·Status: COMPLETED ·Phase: NA