Summary of findings 9. Adverse event outcomes for dietary combined with physical activity interventions compared to no intervention or usual care for preventing obesity in children aged 6 to 12 years.
| Adverse event outcomes for dietary combined with physical activity interventions compared to control for preventing obesity in children aged 6 to 12 years | |||
| Patient or population: children aged 6 to 12 years Setting: school or wider community Intervention: combined dietary and physical activity interventions Comparison: control | |||
| Outcomes | Impact | № of participants (studies) | Certainty of the evidence (GRADE) |
| Underweight Assessed with counts of children assessed as underweight | No effect on number (proportion) of children designated as underweight | 784 (2 RCTs) | ⊕⊕⊕⊝ Moderate1 |
| Depression Assessed with Child's Depression Inventory | Depression was reduced in children in the intervention group (MD −0.21, 95% CI −0.42 to −0.001) Baseline depression score of the control group was 2.09 (SD 2.74) |
225 (1 RCT) | ⊕⊕⊝⊝ Low2 |
| Increased weight concern Assessed with scales for weight concern | No effect of the intervention on concern about weight | 285 (2 RCTs) | ⊕⊕⊕⊕ High |
| Body satisfaction Assessed with Silhouettes scale, Self‐perceived Body Shape scale and the Body Dissatisfaction scale | No effect of intervention (diet and physical activity) on reported body satisfaction at the end of the intervention | 1128 (3 RCTs) | ⊕⊕⊕⊕ High |
| Visits to a healthcare provider | Visits to a healthcare provider were similar in the intervention and control groups; N = 1 in intervention and N = 2 in control | 60 (1 RCT) | ⊕⊕⊝⊝ Low3 |
| Adverse events related to taking of blood samples | < 3%, similar numbers in the intervention (1.6%) and control (1.7%) groups (RD 0.00, 95% CI −0.01 to 0.01) | 4603 (1 RCT) | ⊕⊕⊕⊝ Moderate4 |
| Underweight Assessed with waist circumference of children < 10th centile | Waist circumference of children < 10th centile for weight did not differ between the intervention and control group (P = 0.373) | 724 (1 RCT) | ⊕⊕⊕⊝ Moderate4 |
| Injuries | Similar numbers of children were reported with injuries in the intervention (11%, N = 2) and control (4.7%, N = 1) groups | 60 (1 RCT) | ⊕⊕⊝⊝ Low3 |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; RCT: randomised controlled trial; RD: risk difference | |||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | |||
1Downgraded for risk of bias because one of the studies had an outcome rated as high risk of bias. 2Downgraded for risk of bias as one domain of the bias tool was at high risk of bias. Downgraded for imprecision as the study included only 225 participants. 3Downgraded twice for imprecision, only 60 participants, and only three events. 4Downgraded once for imprecision as there were very few events.