WE Are Active and In This toGetHer (WEIGH): a Randomised Controlled Trial to Ascertain the Feasibility of a Home-based Exercise Programme for People Living With Overweight and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Feasibility and acceptability of the programme through recruitment rate
研究概览
简要总结
The study aims to implement a 12-week home-based exercise programme utilising an online intervention delivery platform. The focus will be on increasing exercise behaviour within the participant's home setting using aerobic, resistance and flexibility exercises as well as behaviour change techniques. Following the programme, semi-structured interviews will be conducted, to explore participant experiences.
It is hypothesised that the exercise programme will be feasible, accessible and acceptable.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥25kg/m² or BMI ≥30kg/m²
- •English speaking
- •Able to follow visual and verbal instructions
- •Access to the internet and accompanying technology (e.g. laptop or tablet)
- •Physically able to undertake aerobic, resistance and flexibility exercise
排除标准
- •Unable to provide informed consent
- •Receiving invasive medical treatment or planned surgery preceding to, or during, the programme
- •Severe mental or physical limitations precluding participation safely in the home environment
- •No access to the internet and/or facilitative technology such as a laptop or tablet
- •Pregnancy
- •Current smoker or vaping.
- •Currently or very recently stopped taking weight loss medication (within the last two weeks)
- •Recently experienced substantial weight change (defined as 5% within 6-12 months)
- •Presence of contraindications to exercise
- •Pacemaker and/or other implanted metal device
- •At high risk of cardiovascular event
结局指标
主要结局
Feasibility and acceptability of the programme through recruitment rate
时间窗: Calculated at trial end, i.e.12 weeks after inclusion.
Recruitment rate will be calculated by dividing the number of eligible candidates by the number who consent to participate.
Feasibility and acceptability of the programme through attrition
时间窗: Calculated at trial end, i.e. 12 weeks after inclusion.
Attrition rate will be defined and calculated as discontinuation of the intervention without return.
Feasibility and acceptability of the programme through adherence
时间窗: Calculated at trial end, i.e. 12 weeks after inclusion.
Adherence will calculated by monitoring the online platform engagement and outputs from post exercise session questionnaires.
Feasibility and acceptability of the programme through intervention engagement
时间窗: Calculated at trial end, i.e. 12 weeks after inclusion.
Engagement will be calculated by monitoring participant's activity on the online platform.
Feasibility and acceptability of the programme through completion rate
时间窗: Calculated at trial end, i.e. 12 weeks after inclusion.
Completion rate will be calculated by dividing the number of participants who successfully complete the programme, by the number of participants that attempt.
Acceptability and experience of the programme via participant interviews
时间窗: Evaluated after intervention period, i.e. up to 12 weeks after inclusion offer.
Interviews will take place between the researcher and participant to explore their experience on the programme and identifying areas for improvement. This may be with participants who completed the intervention, withdrew or declined to participate.
次要结局
- Participant Body Mass (kg)(Taken at baseline, 6 weeks and 12 weeks/programme completion.)
- Participant Body Fat Percentage (%)(Taken at baseline, 6 weeks and 12 weeks/programme completion.)
- Participant resting blood pressure (mmHg)(Taken at baseline, 6 weeks and 12 weeks/programme completion.)
- Participant Body Mass Index (kg/m^2)(Taken at baseline, 6 weeks and 12 weeks/programme completion.)
- Participant Fat Free Mass (%)(Taken at baseline, 6 weeks and 12 weeks/programme completion.)
- Participant Body Fat Mass (kg)(Taken at baseline, 6 weeks and 12 weeks/programme completion.)
- Participant waist to hip ratio(Taken at baseline, 6 weeks and 12 weeks/programme completion.)
研究者
Sofie Power
Principal Investigator
Coventry University