Determining the efficacy of a specific nutritional intervention in Sri Lankan children with malnutrition

Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: There are 13 Medical Officer of Health (MOH) areas in the Nuwara Eliya district, categorized as predominantly rural, estate, urban, or mixed (rural/estate). One MOH area was randomly selected from each category. All children with undernutrition are registered with respective MOHs. They are routinely followed up every month at MOH clinics. Eligible children were listed from the register and identified the PHM area they belong to. Each PHM area was randomly assigned to either the intervention or control using a computer‐generated random sequence (MS Excel, Microsoft Corporation). One PHM area was considered as a cluster, totalling 102 eligible PHM areas. One PHM area was assigned to one nutritional intervention to reduce the likelihood of contamination between study arms through the sharing of the resources. Group assignments were not accessible to either participants or the investigators and were placed in sequentially numbered sealed envelopes before breaking the seal to reveal the assigned group. The control group received standard care (two packs of ready‐to‐eat, corn‐soya blend (Thriposha) as part of existing government safety net programs, and routine health promotion educational sessions every month. Educational sessions were carried out by the public health nurse and the midwives of each medical officer of the health office on breastfeeding, IYCF practices, food health and safety, sanitation, immunization, supplementary programmes and child development. In addition to the above‐mentioned standard care, the experimental group received a food ration (a food basket) every two weeks and an easy‐to‐prepare one‐pot meal recipe booklet and cooking demonstrations using visual aids by the trained study team. The recipe booklet and the composition of the food basket were CONDITION: Prevention of malnutrition in children ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: The percentage of children improving to normal weight/height range (above ‐2 SD) calculated using weight and height, via the WHO Anthro Survey Analyser at baseline and the end of 6 months INCLUSION CRITERIA: 1. Aged 6 to 59 months 2. Weight for height Z scores between <‐2SD to ‐3SD SECONDARY OUTCOME: 1. Weight measured using an electronic scale at baseline and the end of 6 months; 2. Height measured using length board/stadiometer at baseline and the end of 6 months; 3. Weight for age Z score (WAZ) calculated using WHO Anthro Survey Analyser at baseline and the end of 6 months ; 4. Height/age Z score (HAZ) calculated using WHO Anthro Survey Analyser at baseline and the end of 6 months; 5. Weight/height Z score (WHZ) calculated using WHO Anthro Survey Analyser at baseline and the end of 6 months; 6. Mid‐upper arm circumference Z score (MUACZ) measured using a standard MUAC tape at baseline and the end of 6 months; 7. Haemoglobin levels using finger prick method with HaemCue machines at baseline and the end of 6 months; 8. Diet quality measured using the Dietary Diversity Score (DDS) at baseline and the end of 6 months
Epistemonikos ID: 1ebafa866d8ea7f32d2af497d1d90005ad042ff6
First added on: Aug 28, 2024