NCT06599580 Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (Full Scale Trial)
| NCT ID | NCT06599580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Malnutrition, Child |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,400 participants in total. It began in 2025-03-20 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Catherine Oldenburg, ScD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06599580 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 54 Months, studying Malnutrition, Child. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06599580 currently recruiting?
Yes, NCT06599580 is actively recruiting participants. Contact the research team at catherine.oldenburg@uscf.edu for enrollment information.
Where is the NCT06599580 trial being conducted?
This trial is being conducted at Nouna, Burkina Faso.
Who is sponsoring the NCT06599580 clinical trial?
NCT06599580 is sponsored by University of California, San Francisco. The principal investigator is Catherine Oldenburg, ScD at University of California, San Francisco. The trial plans to enroll 2,400 participants.