Online Physical Activity Intervention for Peri- and Post-menopausal Working Women

NCT06821841 | Completed

• 1 other identifier: ETH2425-0016
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Perimenopausal Women; Postmenopausal

Keywords

online physical activity group

Outcome Measures

Primary Outcomes (5)

• Number of participants recruited to the study

  The number of participants recruited will be compared to pre-defined progression criteria, based on existing literature, to examine the feasibility of recruitment. This progression criteria will follow a traffic light system; Green = 40-50 participants, Amber = \>24 participants, Red = \<24 participants.

  9 months from the start of recruitment

• Retention rate of participants attending the online intervention

  The proportion of participants who attend at least half of the online physical activity group sessions, which will be compared to progression criteria; Green = \>50%, Amber = 25-49%, Red = \<25%.

  Week 0 to 8-9

• The retention rate of participants who remain in the study as a whole

  The proportion of participants who remain in the study, compared to progression criteria: Green = \>50%, Amber = 25-49%, Red = \<25%

  Week 0 to 12-13

• Acceptability of the online physical activity group intervention

  Participant responses to the feedback questionnaire, including Likert-scale questions and content analysis of qualitative questions. This will be compared to progression criteria; Green = High satisfaction/acceptability from the majority of participants, with a mean of 7/10 on the Likert-scale questions, Amber = Moderate/Inconsistent satisfaction and acceptability indicated, Red = Low satisfaction/acceptability from the majority of participants

  Week 8-9

• Preliminary indicator of effectiveness for the primary outcome (physical activity)

  Estimate of the between group effect size for the online physical activity group compared to control group on the International Physical Activity Questionnaire-Short Form (IPAQ-SF), from baseline \[Week 0 - 1\] to post-intervention and follow-up \[Week 8-9 and Week 12-13, respectively\]. This will be compared to progression criteria; Green = the between-group effect size is in favour of the intervention, with a substantial number of participants (\>50%) showing reliable change (according to the calculated Reliable Change index; Jacobson \& Truax, 1991), Amber = between-group effect size is in favour of the intervention arm, with a small number of participants showing reliable change (25-49%), Red = between-group effect size is in favour of the control group, with a minimal number of participants in the intervention group showing reliable change (\<25%). For the IPAQ, greater scores indicate higher physical activity levels (better outcome).

  Week 8-9 and 12-13

Secondary Outcomes (3)

• 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

  Week 8-9 and 12-13

• Estimate of between group effect size for the Menopause Rating Scale (MRS) from baseline to post-intervention and 1-month follow-up

  Week 8-9 and 12-13

• 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

  Week 8-9 and 12-13

Other Outcomes (1)

• Test-Retest Reliability of the International Physical Activity Questionnaire-Short Form (IPAQ-SF)

  Week 0-1 (baseline) to week 1-2

Study Arms (2)

Online Physical Activity Group

EXPERIMENTAL

Behavioral: Online Physical Activity Group; Behavioral: Information Leaflet

Control - Information Leaflet Only

OTHER

Behavioral: Information Leaflet

Interventions

Online Physical Activity Group BEHAVIORAL

The online physical activity group will consist of four 45-60-minute sessions, which participants allocated to this group will be asked to commit to. These sessions will be delivered online and occur for 4 weeks. Discussions within the sessions will incorporate motivational interviewing, focussing on the benefits of physical activity, current physical activity levels, barriers to physical activity and overcoming these, motivation to complete physical activity, and goal setting. Participants allocated to this group will receive weekly reminders to promote attendance. Participants will also be asked to complete a weekly physical activity log that includes detail about the type of physical activity they completed, the duration, intensity, context and comments.

Online Physical Activity Group

Information Leaflet BEHAVIORAL

Participants will receive an information leaflet that includes information about menopause (e.g. definition, symptoms), the benefits of physical activity for menopause, recommended weekly physical activity levels (based on CMO guidelines), examples of physical activity, and signposting to online resources. Participants will be able to use the information leaflet as they wish, and complete a weekly physical activity log that includes detail about the type of physical activity completed, the duration, intensity, context and comments.

Control - Information Leaflet Only; Online Physical Activity Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Canterbury Christ Church University: lead

Study Sites (1)

Salomons Institute for Applied Psychology, Canterbury Christ Church University

Royal Tunbridge Wells, Kent, TN1 2YG, United Kingdom

Location

Study Officials

• Dr Fergal Jones

  Canterbury Christ Church University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 12, 2025
• Study Start: May 29, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: March 23, 2026

Record last verified: 2025-06

Locations

GB (1)