Clinical trial NCT06599580: Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (Full Scale Trial)
Official title: Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (MAMAN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Malnutrition, Infant
Malnutrition or Risk of Malnutrition
Hemoglobin Level Measurement
Anemia
Keywords: MUAC (mid-upper arm circumference)
Caregiver screening
malnutrition
home based malnutrition screening
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Sante de Nouna, Burkina Faso
name: Thrasher Research Fund
First posted: 2024-09-19
Enrollment: 2400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: A pilot randomized controlled trial for MAMAN was conducted to find if training caregivers to perform mid-upper arm circumference measurements to screen for malnutrition is feasible. This research will be expanded by assessing caregiver screening for detection of moderate acute malnutrition or severe acute malnutrition relapse with a 1:1:1 randomized controlled trial enrolling caregiver-child dyads of an increased sample size of 1200 dyads, totaling 2400 individuals. This study will address the need for evidence of the effectiveness of caregiver administered mid-upper arm circumference screening in the improvement of outcomes for children who have recovered from severe acute malnutrition. The effectiveness of training caregivers to screen for child malnutrition relapse using mid-upper arm circumference tapes, risk of relapse, speed of relapse detection, and anthropometric outcomes of the children will be analyzed. This will assist in providing evidence to incorporate the routine inclusion of mid-upper arm circumference screening training for all caregivers of children who are being discharged from severe acute malnutrition treatment.

SPECIFIC AIM 1: Determine the effectiveness of training caregivers to screen for relapse to moderate acute malnutrition or severe acute malnutrition using mid-upper arm circumference tapes following recovery from severe acute malnutrition for improving anthropometric outcomes and improving time to relapse detection. It is hypothesized that caregiver screening will be effective for reducing time to detection of relapse and that children receiving caregiver screening will have better anthropometric measures at 6 months post recovery and faster time to detection of relapse among those who relapse.

* Specific Aim 1A: Determine if detection of relapse in children who have recently recovered from severe acute malnutrition is more expeditious when caregivers are trained to screen for relapse to moderate acute malnutrition or severe acute malnutrition using mid-upper arm circumference tapes compared to current standard of care. It is hypothesized that a reduction in time to relapse detection will occur when caregivers are trained to screen for relapse to moderate acute malnutrition or severe acute malnutrition using mid-upper arm circumference tapes.
* Specific Aim 1B: Determine the effectiveness of caregivers screening mid-upper arm circumference measurements on improving anthropometric outcomes for children. It is hypothesized that training for caregiver screening of mid-upper arm circumference will lead to earlier intervention and improved anthropometric outcomes for children at 12 months post-admission.

SPECIFIC AIM 2: Determine the acceptability caregiver mid-upper arm circumference training. It is hypothesized that most survey responses at the 3 and 6-month visits will show high levels of acceptance towards caregiver screening of children using mid-upper arm circumference tapes.

Eligibility criteria: Inclusion Criteria:

* 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
* 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 \> 54 months
* Twins/multiple births
* Children with feeding issues
* Did not recover from severe acute malnutrition 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

Primary outcomes:
measure: Cumulative incidence of relapse
timeFrame: 6 months
Secondary outcomes:
measure: Time to detection of relapse
timeFrame: 6 months
measure: Anthropometric endpoints: weight-for-height Z score (WHZ)
timeFrame: 6 months
measure: Anthropometric endpoints: weight-for-age Z score (WAZ)
timeFrame: 6 months
measure: Anthropometric endpoints: height-for-age Z score (HAZ)
timeFrame: 6 months
measure: Anthropometric endpoints: mid-upper arm circumference (MUAC)
timeFrame: 6 months
measure: Anthropometric endpoints: growth in grams per day
timeFrame: 6 months
measure: Anthropometric endpoints: height change in millimeters per day
timeFrame: 6 months
measure: Anemia
timeFrame: 6 months
measure: Hospitalization
timeFrame: 6 months
measure: Vital status
timeFrame: 6 months
measure: Cumulative incidence of relapse to MAM or SAM separately
timeFrame: 6 months
Other outcomes:
measure: Exploratory: Longer-term endpoints
timeFrame: 12 months
Locations:
city: Nouna
country: Burkina Faso
facility: Centre de recherche en sante de nouna
Study officials:
affiliation: University of California, San Francisco
name: Catherine Oldenburg, ScD
role: PRINCIPAL_INVESTIGATOR
References: