Using Psychological Theory to Promote Physical Activity Among Peri- and Post-menopausal Working Women: A Pilot Randomised-Controlled Trial (RCT).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Retention rate of participants attending the online intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Those who do not meet the inclusion criteria.
结局指标
主要结局
Retention rate of participants attending the online intervention
时间窗: 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%.
Number of participants recruited to the study
时间窗: 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.
The retention rate of participants who remain in the study as a whole
时间窗: 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
时间窗: 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)
时间窗: 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).
次要结局
- 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 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 Work Productivity and Activity Impairment Questionnaire (WPAI) from baseline to post-intervention and 1-month follow-up(Week 8-9 and 12-13)