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It is the purpose of this clinical trial to examine the feasibility and acceptability of a brief online physical activity group (incorporating motivational interviewing) for UK women who are currently experiencing peri- or post-menopausal symptoms and working full-time. To measure feasibility and acceptability, the following will be examined: 1. The ease that participants were recruited; 2. The proportion of participants that remained in the online physical activity group (attending at least half of the sessions); 3. The proportion of participants that remained in the study; 4. How acceptable the participants find the online physical activity group; 5. Whether there is a preliminary indications that the online physical activity group may increase participant activity levels. Once provided informed consent, all participants will be randomly allocated into either the online physical activity group (intervention arm) or the control group. Participants will be asked to complete outcome measures at the same four timepoints, as well as completing a weekly physical activity log.
Full description
This pilot RCT seeks to examine the feasibility and acceptability of an online physical activity group (incorporating motivational interviewing) for UK women experiencing peri- or post-menopausal symptoms and currently working full-time. Having provided informed consent, all participants will be randomly allocated to either the online physical activity group (intervention arm) or control group. Those in the online physical activity group will be invited to attend 4-weekly sessions that last 45-60 minutes, as well as receiving and information leaflet based on Chief Medical Officer (CMO) guidelines. The control group will receive the same information leaflet based on CMO guidelines only and will be able to use this as they wish. Self-report questionnaires will be administered online at the same four timepoints; 1. Baseline (week 0-1) - all participants will complete demographic information, IPAQ, MRS and WPAI; 2. 1-week (week 1) - all participants will complete the IPAQ only; 3. Post-intervention (week 8-9) - all participants will complete the IPAQ, MRS and WPAI. Participants in the intervention arm will complete an additional feedback questionnaire; 4. 1-month follow-up (week 12-13) - all participants will complete the IPAQ, MRS and WPAI. Feasibility and acceptability will be examined by: 1. The ease that participants were recruited; 2. The proportion of participants that remained in the online physical activity group (attending at least half of the sessions); 3. The proportion of participants that remained in the study; 4. How acceptable the participants find the online physical activity group; 5. Whether there is a preliminary indications that the online physical activity group may increase participant activity levels. These outcomes will be examined against pre-defined progression criteria (based on previous literature and outlined in the outcome measures section), to determine whether the intervention is feasible and acceptable to progress to a full-scale RCT at a later date.
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24 participants in 2 patient groups
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Fergal Jones; Emma Cooper
Data sourced from clinicaltrials.gov
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