Perimenopausal WomenNCT06821841
Online Physical Activity Intervention for Peri- and Post-menopausal Working Women
A study testing Online Physical Activity Group and Information Leaflet in people with Perimenopausal Women and Postmenopausal, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Perimenopausal Women, Postmenopausal
- What is being tested?
- Online Physical Activity Group and Information Leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 May 2025to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Those who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salomons Institute for Applied Psychology, Canterbury Christ Church University
Royal Tunbridge Wells, Kent, TN1 2YG
About this study
Official title: Using Psychological Theory to Promote Physical Activity Among Peri- and Post-menopausal Working Women: A Pilot Randomised-Controlled Trial (RCT).
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.
Read the 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.
- Conditions
- Perimenopausal Women, Postmenopausal
- Being tested
- Online Physical Activity Group, Information Leaflet
- Keywords
- online physical activity group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Physical Activity GroupBehavioural
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.
Information LeafletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online Physical Activity Group | Experimental | Not described Receives: Behavioral: Online Physical Activity Group; Behavioral: Information Leaflet |
| Control - Information Leaflet Only | Other | Not described Receives: Behavioral: Information Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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%
Measured: 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
Measured: 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).
Measured: 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
Estimate of the between group effect size of the online physical activity group compared to control group on change on the International Physical Activity Questionnaire - Short Form (IPAQ-SF) from baseline (week 0-1) to post intervention (week 8-9) and follow-up (week 12-13). The IPAQ-SF is a 7-item questionnaire that assesses an individual's physical activity levels (e.g. walking, moderate-intensity, vigorous-intensity) and sedentary behaviour (e.g. sitting). Higher scores on the IPAQ-SF indicates more physical activity.
Measured: 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
Estimate of the between group effect size of the online physical activity group compared to control group on change on the Menopause Rating Scale (MRS) from baseline (week 0-1) to post-intervention (week 8-9) and follow-up (week 12-13). The MRS is an 11-item questionnaire that assesses the severity of various menopausal symptoms (somatic, psychological and urogenital) using a 5-point Likert-scale. Higher scores on the MRS indicate greater symptoms severity.
Measured: 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
Estimate of the between group effect size of the online physical activity group compared to control group on the change on the Work Productivity and Activity Impairment Questionnaire (WPAI) from baseline (week 0-1) to post-intervention (week 8-9) and follow-up (week 12-13). The WPAI is a self-report questionnaire that measures the impact of a specific health difficulty on work (e.g. absenteeism, work productivity) and daily activities (e.g. household chores, hobbies). Higher scores on the WPAI indicate greater impact on work.
Measured: Week 8-9 and 12-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start29 May 2025
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Fergal Jones, Study chair, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821841
- Sponsor's protocol ID
- ETH2425-0016
- Status last verified
- Jun 2025
- First submitted
- 11 Feb 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Psychological Theory to Promote Physical Activity Among Peri- and Post-menopausal Working Women: A Pilot Randomised-Controlled Trial (RCT).
- ClinicalTrials.gov ID
- NCT06821841
- Acronym / sponsor ID
- ETH2425-0016
- Conditions
- Perimenopausal Women, Postmenopausal
- Keywords
- online physical activity group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Physical Activity Group | Experimental | Behavioral: Online Physical Activity Group, Behavioral: Information Leaflet |
| Control - Information Leaflet Only | Other | Behavioral: Information Leaflet |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Those who do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Physical Activity GroupThe 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. | Behavioural | Online Physical Activity Group |
| Information LeafletParticipants 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. | Behavioural | Control - Information Leaflet Only, Online Physical Activity Group |
Primary outcome
Number of participants recruited to the study
Time frame: 9 months from the start of recruitment
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.
Retention rate of participants attending the online intervention
Time frame: Week 0 to 8-9
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%.
The retention rate of participants who remain in the study as a whole
Time frame: Week 0 to 12-13
The proportion of participants who remain in the study, compared to progression criteria: Green = >50%, Amber = 25-49%, Red = <25%
Acceptability of the online physical activity group intervention
Time frame: Week 8-9
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
Preliminary indicator of effectiveness for the primary outcome (physical activity)
Time frame: Week 8-9 and 12-13
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).
3 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: Week 8-9 and 12-13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Fergal Jones study chair
Canterbury Christ Church University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Physical Activity Group and Information Leaflet in people with Perimenopausal Women and Postmenopausal, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited to the study (time frame: 9 months from the start of recruitment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.