Muhoozi 2018.
Study characteristics | ||
Methods | Cluster‐RCT | |
Participants | Study setting: the study was conducted in Kabale and Kisoro districts in southwestern Uganda because of the high prevalence of stunting (UBOS ‐ Uganda Demographic and Health Survey, 2011). Town centres were excluded to minimise differences in socio‐economic status and feeding practices. People living in the study area are predominantly small‐scale farmers. Both districts are densely populated and are made up of several sub‐counties, each consisting of 18 to 25 villages Inclusion criteria: children between 6 and 8 months of age Exclusion criteria: households with a child having a congenital malformation, a physical disorder that would influence assessments and/or nutrient intake, and/or a diagnosis of mental or brain illness, as reported by the mother or by a health worker A total of 511 infants were enrolled, of whom 263 (139 males) were in the nutritional counselling group and 248 (123 males) were in the no intervention group. There were no apparent differences between intervention and control groups at baseline |
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Interventions | Intervention group: nutrition education was delivered via 3 group meetings over a period of 6 months to 26 groups of mothers (4 to 12 mothers per group). It was delivered by a trained education team and included 2 behaviour change techniques: Providing information and prompt practice (i.e. demonstrations of preparing food and stimulating children) Control group: routine care |
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Outcomes | Weight‐for‐age z score at 12 months Height‐for‐age z score at 12 months Weight‐for‐height z score at 12 months Head circumference z score at 12 months Bayley Scales of Infant and Toddler Development III scales (cognitive) at 12 to 16 months |
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Identification | Sponsorship source: study is funded by the Throne Holst Foundation and the University of Oslo Author's name: Per O. Iversen Institution: University of Oslo Email: p.o.iversen@medisin.uio.no Address: Department of Nutrition, Institute of Basic Medical Sciences, University of Oslo, P.O. Box 1046, Blindern, 0317 Oslo, Norway |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote. "By use of computer‐generated random numbers, villages whose assigned number matched with the random numbers were selected" |
Allocation concealment (selection bias) | Low risk | Although investigators were not blinded of the numbers given to each village as the villages were listed alphabetically and were numbered in ascending order, use of computer‐generated random numbers to select the village will reduce allocation concealment bias |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The intervention is not amenable to blinding of participants or of personnel delivering the intervention; however, outcomes (growth and development) included in this review are unlikely to be affected by lack of blinding of participants |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Growth and development outcome assessors were blinded to the allocation as stated in Muhoozi 2018. Outcome assessors for Atukunda 2019 outcomes (child development at 36 months) were blinded, but all other outcomes measured previously were not assessed by blinded assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition bias was unclear as proportionate sampling was used to obtain 10 sub‐counties (6 out of 19 in Kabale, and 4 out of 14 in Kisoro) to participate in the study. Researchers used a 3‐stage procedure to obtain households for the study. Hence, only a sub‐sample of a population that has received the intervention participated in the study and had outcome measures obtained. This is an appropriate method for a large‐scale community study, However, risk of attrition bias is unclear. The follow‐up study (Atukunda 2019) included only patients from January to May 2014. This may be fully representative of the whole recruited sample, as this represents only 30% of the original sample size |
Selective reporting (reporting bias) | Low risk | All proposed outcomes were reported |
Other bias | Low risk |