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4F FITNESS & Wellnes Group

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The randomised stepped-wedge cluster trial design had two steps with four clusters (antenatal clinics). All clinics undertook the control group period prior to the intervention group period. The two clinics randomised to sequence 1 undertook these immediately, the two clinics randomised to sequence 2 undertook their control group period 12 weeks later. Randomisation was undertaken after clinic consent to take part in the trial was obtained. The studys statistical advisor generated a computer randomisation list with a block size of 2, which was applied to the presupplied clinic list by the trial team. Separate cohorts of participants were recruited for each period to the control group and the intervention group, ensuring all participants began the study 46 months through their pregnancy. The 12-week phase for both the control and intervention group included data collection at week 1 (baseline) and week 7 (post-intervention) after either participating in the intervention sessions (CHIME) or standard care (control). Data were also collected at week 11 (follow-up), 4weeks after the intervention finished. This study is reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement: extension to randomised pilot and feasibility trials.31

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The two questionnaires completed by participants at baseline (T0) and at the end of the intervention (T5) and the two questionnaires completed by health care providers (physicians and nurses) at the clinics are shown in supplemental data 4 and supplemental data 5, respectively.


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