A 1:1:1 individually randomized unmasked controlled trial is proposed in which caregivers will be trained to screen their children who have recovered from an episode of SAM (severe acute malnutrition) using MUAC (mid-upper arm circumference) tapes. One arm will include caregiver screening with a mid-upper arm circumference tape and usual monthly follow-up schedule for the first 3 months post enrollment and a final follow-up at 6 months. Another arm will include caregiver screening with a mid-upper arm circumference tape and a reduced follow-up schedule for one visit at 3 months and a final visit at 6 months. The third arm will adhere to the current standard of care, which is no caregiver training to conduct mid-upper arm circumference screenings and monthly clinic-based follow-up appointments for 3 months with a final visit at 6 months post enrollment. Children aged 6-54 months with a documented recovery from uncomplicated severe acute malnutrition that was managed in a participating outpatient nutritional program and their caregivers will be eligible for inclusion in the trial. Caregivers will be trained to screen their children weekly for 6 months following discharge from the nutritional program and will be counseled to bring their child back to the nutritional program should their mid-upper arm circumference value fall in the red zone of the mid-upper arm circumference tape (\< 11.5 cm). All children will be seen at 3 and 6 months for the primary outcome assessment. By conducting this study, our primary goal is to determine if training caregivers to screen their children for relapse to MAM (moderate acute malnutrition) or SAM (severe acute malnutrition) using mid-upper arm circumference tapes following recovery from SAM (severe acute malnutrition) will reduce the risk of relapse. An additional aim is to assess the level of acceptability of caregivers screening children for malnutrition using mid-upper arm circumference tapes from both a clinic and caregiver perspective.
Caregiver's aged 18 years old or older or a legal guardian or a relative aged 18 or older
Child aged 6-54 months
Child has recovered from an episode of severe acute malnutrition per Burkinabè national guidelines (weight-for-height ≥ -2 and/or mid-upper arm circumference ≥ 12.5 cm in the past month, with the criterion used for admissions corresponding to the original admission criteria)
Family is planning to stay in the study area for 6 months
Caregiver age under 18 years old, or legal guardian or relatives under 18 years old
Child age < 6 months or > 54 months
Twins/multiple births
Children with feeding issues
Parallel
Training caregivers to screen children for malnutrition relapse
BehavioralCaregivers enrolled in the trial who are assigned to the two experimental arms, will be provided mid-upper arm circumference tapes and trained on how to screen their child for malnutrition relapse and asked to bring their child back to the clinic if relapse is detected.
Reduced follow-up schedule
Other interventionCaregivers in one of the caregiver mid-upper arm circumference screening arms, will be asked to adhere to a reduced follow-up clinic visit schedule for when they bring their child to the clinic for planned visits. The standard of care includes monthly visits for the first 3 months post recovery, but those randomized to the reduced follow-up schedule arm, will not bring their child to the clinic for planned visits 1 month and 2 months after baseline.
Cumulative incidence of relapse
The primary outcome will be defined as the proportion of children who relapse to global acute malnutrition (either moderate acute malnutrition with mid-upper arm circumference \< 12.5 cm to ≥ 11.5 cm and/or weight-for-height Z score \< -2 to ≥ -3 or severe acute malnutrition with mid-upper arm circumference \< 11.5 cm and/or weight-for-height Z score \< -3) by the 6 month primary endpoint randomized by study assignment.
Time to detection of relapse
The amount of time until the detection of malnutrition relapse will be assessed as a secondary outcome and will be defined as the time from the baseline visit until the planned or unplanned visit when malnutrition relapse is detected. This will be measured up until the 6 month visit and will be assessed by randomized study assignment.
Cumulative incidence of relapse to MAM or SAM separately
The proportion of children by randomized allocation who relapse to MAM or to SAM analyzed separately.
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University of California, San Francisco
Lead sponsor
Centre de Recherche en Sante de Nouna, Burkina Faso
Collaborator
Thrasher Research Fund
Collaborator