Severe Acute Malnutrition
Conditions
Brief summary
The investigators propose a pilot randomized controlled trial to train mothers to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.
Detailed description
While interventions prioritizing rapid weight gain have led to improved survival for children with severe acute malnutrition (SAM), prevention of relapse to SAM after recovery is essential to improve long-term outcomes for children beyond survival. Mothers have been successfully trained to screen for new-onset SAM in community-based settings and perform as well as community health workers for detecting SAM. Here, the investigators propose a pilot randomized controlled trial in which mothers will be trained to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed. SPECIFIC AIM 1: Determine the feasibility of training mothers to screen for relapse among children recovering from SAM compared to standard of care for early detection of relapse and re-entry to care. The investigators hypothesize that relapse will be detected earlier in children whose mothers have been trained to screen for relapse compared to standard of care (no mother screening). Specific Aim 1A: Determine the burden of post-discharge relapse among children recovered from an episode of SAM in Boromo, Burkina Faso. The investigators hypothesize that \>25% of children who have recovered from SAM in the study facilities will relapse within a 6-month period following their discharge. Specific Aim 1B: Determine the acceptability and feasibility of training mothers to screen for relapse after discharge among children recovered from SAM. the investigators hypothesize that mothers will find MUAC screening acceptable and that training them will be feasible, as demonstrated by time and costs for training, willingness to participate in training, and follow-up in the trial. SPECIFIC AIM 2: Determine the accuracy of mother-based screening for relapse among children recovering from SAM compared to a gold standard anthropometrist. the investigators hypothesize that mother screening will have a sensitivity and specificity of \> 80% for the detection of relapsed SAM (MUAC \< 11.5 cm) compared to screening by a trained anthropometrist. the investigators anticipate that the result of this pilot will provide evidence supporting the acceptability, feasibility, and accuracy of mother screening for relapse among children with SAM. The data generated during this pilot will be used to support the development of a full-scale randomized controlled trial and will be used as preliminary data supporting an R01-level NIH application. These data will help establish a new line of work for our research team in the management of acute malnutrition, which builds on existing expertise in randomized controlled trials and antibiotic-based interventions for child survival and reduction of morbidity, including as part of the management of uncomplicated SAM.
Interventions
Mothers will be trained to perform MUAC weekly on their children
Sponsors
Study design
Masking description
Outcomes assessor and investigator will be masked to intervention. In regards to the intervention, participants and care providers won't be masked.
Intervention model description
Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse
Eligibility
Inclusion criteria
* Caregiver's aged 18 years old or older or a legal guardian or a relative aged 18 or older * Child aged 6-59 months * Child has recovered from an episode of SAM per Burkinabè national guidelines (WHZ ≥ * 2 and/or MUAC ≥ 12.5 cm in the past month * Family is planning to stay in the study area for 6 months * Appropriate consent from the caregiver or guardian
Exclusion criteria
* Caregiver age under 18 years old, or legal guardian or relatives under 18 years old * Child age \< 6 months or \> 59 months * Twins/multiple births and children with feeding issues * Did not recover from SAM in the past month * Family is planning to move out of the study area in the next 6 months * Caregiver or guardian refuses to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Detection of Relapse | 6 months | Time to relapse using a log-rank test with a term for randomized treatment assignment will be used. Relapse will be defined using the Burkina Faso guideline for detecting malnutrition (MUAC \< 11.5 cm and / or weight-for-height Z-scores WHZ \< -3 SD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight for Height Z Score (WHZ) | 6 months | Weight-for-height Z-score (WHZ) is the number of standard deviations a child's weight-for-height differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher WHZ values indicate better nutritional status, while lower values indicate greater wasting. WHZ below -2 SD indicates wasting, and WHZ below -3 SD indicates severe wasting/severe acute malnutrition. There is no fixed minimum or maximum value for this standardized Z-score. |
| Weight-for-age Z-score (WAZ) | 6 months | Weight-for-age Z-score (WAZ) is the number of standard deviations a child's weight-for-age differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher WAZ values indicate better nutritional status, while lower values indicate greater underweight. WAZ below -2 SD indicates underweight, and WAZ below -3 SD indicates severe underweight. There is no fixed minimum or maximum value for this standardized Z-score. |
| Height-for-age Z-score (HAZ) | 6 months | Height-for-age Z-score (HAZ) is the number of standard deviations a child's height-for-age differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher HAZ values indicate better linear growth, while lower values indicate greater stunting. HAZ below -2 SD indicates stunting, and HAZ below -3 SD indicates severe stunting. There is no fixed minimum or maximum value for this standardized Z-score. |
Countries
Burkina Faso
Contacts
University of California, San Francisco
Participant flow
Pre-assignment details
A total of 200 mother/caregiver-child dyads were enrolled, representing 400 individual participants: 200 mothers/caregivers and 200 children. The Protocol Enrollment number and Participant Flow milestones represent individual participants. Comments indicate the corresponding number of mothers/caregivers, children, and dyads for each milestone.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 15 months |
| Caregiver age | 26 years |
| Caregiver education College or above | 3 Participants |
| Caregiver education None | 82 Participants |
| Caregiver education Primary | 21 Participants |
| Caregiver education Secondary | 6 Participants |
| Caregiver occupation Agriculture | 5 Participants |
| Caregiver occupation Household | 93 Participants |
| Caregiver occupation Other | 0 Participants |
| Caregiver occupation Retail | 3 Participants |
| Caregiver relationship Grandmother | 3 Participants |
| Caregiver relationship Mother | 98 Participants |
| Height-for-age Z-score (HAZ) | -1.9 z-score STANDARD_DEVIATION 1.4 |
| Hemoglobin | 10.3 g/dL |
| Household dietary diversity was reported by the mother/caregiver and reflects household-level dietar | 10 units on a scale |
| Household food insecurity was reported by the mother/caregiver and reflects household-level food acc Food secure | 39 Participants |
| Household food insecurity was reported by the mother/caregiver and reflects household-level food acc Mildly food insecure | 18 Participants |
| Household food insecurity was reported by the mother/caregiver and reflects household-level food acc Moderately food insecure | 21 Participants |
| Household food insecurity was reported by the mother/caregiver and reflects household-level food acc Severely food insecure | 37 Participants |
| Mid-upper arm circumference (MUAC) | 13 cm |
| Number of children <5 years in household | 2 children in household |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 198 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Burkina Faso | 400 participants |
| Sanitary installation Improved pit latrine | 13 Participants |
| Sanitary installation Simple latrine with slab | 83 Participants |
| Sanitary installation Simple sand dale latrine | 11 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 48 Participants |
| Water source Other | 1 Participants |
| Water source Protected dug well | 47 Participants |
| Water source Running water or tubewell | 53 Participants |
| Water source Unprotected dug well | 1 Participants |
| Weight-for-age Z-score (WAZ) | -2.1 z-score STANDARD_DEVIATION 0.9 |
| Weight for Height Z Score (WHZ) | -1.5 z-score STANDARD_DEVIATION 0.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 4 / 101 |
| other Total, other adverse events | 0 / 99 | 0 / 101 |
| serious Total, serious adverse events | 3 / 99 | 9 / 101 |