Rafieya‐Kopaei 2019.
| Study characteristics | ||
| Methods | Cluster‐RCT | |
| Participants | Study setting: 6 public health centres located in downtown Isfahan (centre of Iran), which were similar in terms of economic, social, and cultural conditions, were chosen Inclusion criteria: mothers with infants aged 4 months to 4 months and 29 days. Infants were singleton and exclusively breastfed and had a gestational age of 37 to 42 weeks and no disease or disorder. In addition, there was no medical restriction to continue exclusive breastfeeding for up to 6 months of age. Other inclusion criteria were literacy; having a Smartphone and telegram, an open‐source global messaging service, and Soroush ‐ a national open‐source messaging service; ability to work with these apps; and consent to co‐operate with the researcher Exclusion criteria: as above Total of 90 infants were enrolled: 60 (29 (48%) males) infants were enrolled in the intervention group and 30 (14 (47%) males) in the control group. There was no difference in baseline demographics between groups |
|
| Interventions | Intervention group: nutrition education was delivered via text messages in the form of gain framed (Group 1) and loss framed (Group 2). Educational messages were based on the book printed by the Ministry of Health used at healthcare centres of Isfahan, instructions on complementary feeding by the Ministry of Health, and guidelines on complementary feeding by the World Health Organization Control group: no text messages |
|
| Outcomes | Weight and head circumference at 8 months Exclusive breastfeeding at 6 months |
|
| Identification | Sponsorship source: Isfahan University of Medical Sciences Author's name: Fereshteh Zamani‐Alavijeh Institution: Isfahan University of Medical Sciences Email: fe.zamani@gmail.com; fe.zamani@hlth.mui.ac.ir; Address: Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jarib Avenue, Isfahan 81676‐36954, Iran |
|
| Notes | No data were available for inclusion in the meta‐analysis Growth: no significant difference was observed between intervention (gain‐ and loss‐framed) groups and the control group regarding growth status of children (weight and head circumference) and its trend and z score from birth to 8 months of age Exclusive breastfeeding: frequency of exclusive breastfeeding until 6 months was significantly higher in the loss‐framed group (P = 0.03) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "At first, six public health centers located in downtown Isfahan, which were similar in terms of economic, social and cultural conditions, were selected and randomly divided into three groups, including GF (Gain Frame) experimental group, LF (Loss Frame) experimental group, and CG (control group). In the next stage, 32 mothers were selected from each group (96 mothers in total) through simple random sampling" Random sampling was reported to have been used but the method of sampling was not defined |
| Allocation concealment (selection bias) | Low risk | Quote: "Assignment carried out by a lottery performed by someone outside the research team" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Due to the nature of the intervention, the trainer (the first author) was not blind to the allocation of groups to gain‐framed and loss‐framed categories. However, the participants and the statistics advisor (the third author) were blind to allocations" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Due to the nature of the intervention, the trainer (the first author) was not blind to the allocation of groups to gain‐framed and loss‐framed categories. However, the participants and the statistics advisor (the third author) were blind to allocations." This should not affect objective measurement of growth parameters |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 90 of 96 infants (94%) completed the study |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | There was no difference in baseline demographics |