Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599580
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition Full Scale Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition MAMAN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAMAN
Brief Summary:
A 111 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 115 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 improve anthropometric outcomes by improving time to relapse detection 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 111 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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None