Clinical trial NCT06821841: Pilot Trial of an Online Physical Activity Intervention for Peri- and Post-menopausal Working Women
Official title: Using Psychological Theory to Promote Physical Activity Among Peri- and Post-menopausal Working Women: A Pilot Randomised-Controlled Trial (RCT).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perimenopausal Women
Postmenopausal
Keywords: online physical activity group
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 24
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 30-60 years
* Currently working full-time (approximately 35+ hours per week)
* Currently experiencing perimenopausal (women with newly inconsistent menstrual cycles, \>1 year since last cycle) or post-menopausal (cessation of menstrual cycle for \>12 months) symptoms, which are impacting functioning
* Currently physically inactive or not meeting recommended government guidelines (150-minutes of moderate-vigorous physical activity per week)
* No comorbid health conditions that impact ability to participate in physical activity

Exclusion Criteria:

- Those who do not meet the inclusion criteria.

Primary outcomes:
measure: Number of participants recruited to the study
timeFrame: 9 months from the start of recruitment
measure: Retention rate of participants attending the online intervention
timeFrame: Week 0 to 8-9
measure: The retention rate of participants who remain in the study as a whole
timeFrame: Week 0 to 12-13
measure: Acceptability of the online physical activity group intervention
timeFrame: Week 8-9
measure: Preliminary indicator of effectiveness for the primary outcome (physical activity)
timeFrame: Week 8-9 and 12-13
Secondary outcomes:
measure: Estimate of between group effect size for change on the International Physical Activity Questionnaire-Short Form (IPAQ-SF) from baseline to post-intervention and 1-month follow-up
timeFrame: Week 8-9 and 12-13
measure: Estimate of between group effect size for the Menopause Rating Scale (MRS) from baseline to post-intervention and 1-month follow-up
timeFrame: Week 8-9 and 12-13
measure: Estimate of between group effect size for the Work Productivity and Activity Impairment Questionnaire (WPAI) from baseline to post-intervention and 1-month follow-up
timeFrame: Week 8-9 and 12-13
Other outcomes:
measure: Test-Retest Reliability of the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
timeFrame: Week 0-1 (baseline) to week 1-2
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Salomons Institute for Applied Psychology, Canterbury Christ Church University
state: Kent
Study officials:
affiliation: Canterbury Christ Church University
name: Dr Fergal Jones
role: STUDY_CHAIR
References: