Context
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• Data collected on a site proforma detailing site demographics, ethnicity, size, services delivered etc.
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• Data on those delivering the intervention
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• Data from two site observations completed at different time points in the intervention delivery period using a structured observation guide.
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• Contextual issues explored in the staff focus groups and participant interviews
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Reach
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• Attendance at the group sessions
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• Comparison of characteristics of those attending the intervention with those not attending
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• Reach explored in the staff focus groups and participant interviews
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Exposure
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• Number of group sessions delivered
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• Data from group session summary forms which describe those attending and the content/timings of sessions
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• Data from site observations (two per site)
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• Attendance at group sessions
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• Exposure and attendance explored in the staff focus groups and participant interviews
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• Data gathered on use of pedometers, step targets and walking diary completion
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Fidelity
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• Data from site observations (two per site)
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• Data from group session summary forms which describes how the intervention was implemented at each session
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• Fidelity explored in the staff focus groups and participant interviews
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Recruitment
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• Comparison of demographics of sites recruited
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• Recruitment rates compared across sites in terms of how many recruited, who is recruited and also how quickly people are recruited
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• Comparison of potentially eligible women with those recruited using data from case report forms and screening forms
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• Recruitment issues explored in the staff focus groups and participant interviews
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Retention
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• Dropout by trial arm
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• Dropout by site
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• Comparison of demographics of those dropping out with those remaining
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Contamination
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• Participants asked what other services control group utilised in case report forms
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• Contamination explored in the staff focus groups and participant interviews
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Theory testing |
• Mediation analyses using questionnaire data
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• Theoretical mediators explored in the staff focus groups and participant interviews |