Craigie 2011.
Methods | Computer‐based randomisation, using a 1:1 random sampling procedure. | |
Participants | 52 women who were not pregnant, 6‐18 months postpartum with a BMI > 25 kg/m2 living in areas of deprivation within Tayside, UK. | |
Interventions | Intervention: the 12‐week intervention were allocated a trained lifestyle counsellor who delivered the intervention by 3 face‐to‐face consultations at monthly intervals and 3 structured telephone calls between consultation to identify progress towards goals and challenges. A personalised dietary prescription of estimated energy requirements minus 500 kcal was calculated with verbal and written guidance on food groups, frequency of consumption and portion size. Personalised physical activity goals were also set towards achieving 150 minutes of moderate to vigorous activity per week. Participants were provided with 4‐week walking plans, a pedometer and a weight logbook for self‐monitoring. Control: the group received usual care and 1‐off consultation with a lifestyle counsellor after follow‐up assessment. All participants received a weight loss booklet. Trial duration: medium‐term. |
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Outcomes | Postpartum weight loss, percentage of women who had weight loss of clinical significance, change in percentage of body fat, and feasibility and acceptability of the intervention. Other outcomes not considered in this review: change in waist circumference, BMI and minutes of moderate‐vigorous physical activity per day. |
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Notes | 65 women met the inclusion criteria and were appointed for a baseline visit but 11 women subsequently declined to participate and 2 were excluded due to low BMI. In total 52 women enrolled in the study. Loss to follow‐up was 31% (24% and 39% for intervention and control group respectively) including 3 participants who became pregnant during the study and were excluded. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | Randomisation was computer‐based. |
Allocation concealment | Unclear risk | No detail provided. |
Blinding All outcomes | Low risk | Assessments were performed, primarily within a hospital setting but on occasions within the participants’ home, by a research assistant blinded to randomisation allocation. |
Incomplete outcome data addressed All outcomes | High risk | 31% of loss to follow‐up. |
Free of selective reporting | Low risk | Outcomes of relevance described. |
Free of other bias | Low risk | Supported by the Medical Research Council (Ref GO701771) and NHS Research Scotland (NRS) through NHS Tayside. No mention of any research protocol published a priori. The characteristics of participants were not significantly different between groups at baseline. |