Malnutrition
Conditions
Brief summary
This project explores whether children have better growth and cognitive development when the clinic identifies higher risk MAM children and support them either with the same treatment as SAM children or with the recommended practice: nutrition counseling.
Detailed description
This is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in Sierra Leone. All participants will be children aged 6-59 months. Control participants will have moderate acute malnutrition (MAM), defined as mid-upper arm circumference (MUAC) 11.5-\<12.5. High Risk MAM will be defined with a MUAC 11.5 to \<11.9 or WAZ\<-3.5 or Mother not the caretaker or not breastfeeding at \<2 years old. Low risk MAM defined with a MUAC 11.9 to \<12.5 with no risk factors. Control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment. High risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of RUTF per day till MUAC is equal to or greater than 12.5 or up to 12 weeks of treatment. Their caregiver will also receive nutrition education via the mother care groups. The investigators will also follow up with the participant at 12 and 24 weeks post-enrollment. A subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. Investigators will also enroll health adult participants for eye tracking assessment. Adult data will be used as a reference when interpreting results.
Interventions
DRUGamoxicillin
At enrollment the child will receive a 1 week course of amoxicillin
DIETARY_SUPPLEMENTReady-to-use therapeutic food (RUTF)
1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed
BEHAVIORALMother Care group
Nutrition education via mother care groups lead by a respected elder in the local community
Sponsors
Centre for Global Child Health, Hospital for Sick Kids, Toronto, Canada
Department of Psychology, University of Tampere, Finland
Project Peanut Butter, Sierra Leone
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* uncomplicated MAM (based on MUAC equal to or greater than 11.5 cm and \<12.5)
Exclusion criteria
* currently involved in another research trial or feeding program * medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia * have a diagnosed or visible sign of developmental delay * have a history of peanut or milk allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery from moderate acute malnutrition (MAM) | up to 12 weeks of treatment | proportion of participants recovered based on mid-upper arm circumference(MUAC) Recovery is defined as MUAC greater than or equal to 12.5cm before or at 12 weeks after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants deterioration to severe acute malnutrition(SAM) | Duration of the study 24 weeks post-enrollment | Proportion of participants that deteriorate from moderate acute malnutrition(MAM) to severe acute malnutrition(SAM). SAM is defined at mid-upper arm circumference(MUAC)\<11.5 or presence of oedema. |
| Participants that remain or become underweight using weight for age z-score | 24 weeks post-enrollment | the difference between the weight for age z-score(WAZ) from enrollment to 24 weeks post-enrollment |
| Participant survival rates | Duration of the study 24 weeks post-enrollment | Proportion of participants survival rates during the study |
| Participants that remain or become Wasted | 24 weeks post-enrollment | the difference between weight for length z-score(WHL) from enrollment to 24 weeks post enrollment |
| Eye tracking performance for cognitive development | 24 weeks post enrollment | the difference between the eye tracking performance from enrollment to 24 weeks post enrollment |
| Participants that remain or become Stunted | 24 weeks post-enrollment | the difference between length for age z-score(LAZ) from enrollment to 24 weeks post enrollment |
Countries
Sierra Leone
Outcome results
None listed