Kuusipalo 2006.

Methods	Study date: 2006. Study design: RCT, not cluster, with 7 intervention arms and 1 control. Intervention arms were varying intensity of spreads with 2 different formulations: soy and milk
Participants	SES or context: Low‐ and middle‐income country: Rural Malawi. Most children were undernourished. Study conducted during rainy season when food security is the lowest and weight and height gain of the children is poorer than the rest of the year. Exclusive breastfeeding is almost non‐existent and diet is complemented with maize Nutritional status: Weight‐for‐age < ‐2, weight greater than 5.5 kg, and WHZ greater than ‐3 Age: 6 ‐ 17 months Number: Total: 128 started (18, 18, 18, and 9 children received 5, 25, 50, and 75 g of milk‐based fortified spread, respectively; 20, 18, and 9 children received 25, 50, and 75 g of soy‐based fortified spread, respectively). 125 finished. 18 ‐ 19 in each group, control = 18 Sex: Both
Interventions	Intervention: Feeding only with seven different intervention arms: Milk‐based fortified spread and soy‐based fortified spread of different quantities Energy: Supplementation provided 96, 544, 1105, and 1661 kcal and 1, 4, 8, and 11 g of protein in 5, 25, 50, and 75 g of milk‐based fortified spread, respectively. It provided 531, 1071, and 1615 kcal and 3, 7, and 10 g of protein in 25, 50, and 75 g of soy‐based fortified spread, respectively. Supplements delivered to homes prepackaged weekly for first 4 weeks and bi‐weekly thereafter Duration: 12 weeks % DRI for energy: Milk‐based formula 6 ‐ 12 months = 28.57% (avg.), soy‐based formula 6 ‐ 12 months = 35.98% (avg.), milk‐based formula 12 ‐ 24 months = 23.44% (avg.), soy‐based formula 12 ‐ 24 months = 29.52% (avg.) % DRI for protein: Milk‐based formula 6 ‐ 12 months = 68.84% (avg), soy‐based formula 6 ‐ 12 months = 76.50% (avg.), milk‐based formula 12 ‐ 24 months = 60.38% (avg.), soy‐based formula 12 ‐ 24 months = 67.10% (avg.) *Because it provided more of the DRI for energy, we used the children who received the 75 g soy‐based formula as our experimental group Control: No feeding programme Provider: Foundation for Paediatric, Research in Finland, and Medical Research Fund of Tampere Supervised: No, but empty sachets from the previous week were collected. Sometimes nurses visited homes during feeding time Compliance: No, but empty sachets from the previous week were collected
Outcomes	Physical: Haemoglobin, height, weight, WAZ, HAZ, WHZ
Notes	At a daily dose of 25 and 50 g, spreads are somewhat more expensive than micronutrient‐fortified corn‐soy flour, tablets or sprinkles. USD 0.10 ‐ 0.20/day vs USD 0.02 ‐ 0.04/day
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised by computer‐generated lists
Allocation concealment (selection bias)	Unclear risk	Nothing mentioned
Baseline outcome measurements	Low risk	Very little (and non‐significant) difference in weight, heights, WAZ, HAZ, WHZ
Baseline characteristics	Unclear risk	Not applicable
Incomplete outcome data (attrition bias) All outcomes	Low risk	Only 3 dropped out
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Said that research assistant and lab assistant performing outcome assessment remained blinded until end of study
Blinding of participants and personnel (performance bias) All outcomes	High risk	For the comparison against the "untreated" group, there was no placebo, but within different energy‐densities, participants were blinded. "Thus, in total, 7 different supplementation groups and 1 unsupplemented group (that received no placebo spread) were included in the study. Soy‐containing formulas tasted slightly sweeter than the milk‐containing ones, but otherwise the look, taste and packing of different formulas were identical"
Protection from contamination	Unclear risk	Not applicable
Selective reporting (reporting bias)	Unclear risk	No access to protocol