A Free-living, Walking-based, Exercise Programme, With Exercise Timed Relative to Breakfast, to Improve Metabolic Health in People Living With Obesity: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Compliance
研究概览
简要总结
The aim of this study is to investigate the effectiveness of a home-based walking-based exercise intervention undertaken in the fed or fasted state to improve glycaemic control in overweight and obese individuals. This study will evaluate the adherence and compliance to this "real-world" exercise programme that requires no face-to-face contact with the research team. It is also hypothesised that individuals who exercise before breakfast (fasted) will see greater improvements in glycaemic control than those who exercise after breakfast.
详细描述
Individuals with a BMI above 28 will be recruited to investigate whether a home-based walking exercise intervention in the fasted or fed state is feasible to implement into real-world situation. Secondary to that, this study will investigate whether a fasted or fed intervention more effective for improving metabolic health. To do this, individuals will provide written consent, and then carry out baseline measures in their own home:
Waist-to-hip ratio and weight: Participants will be provided with a tape measure to measure waist circumference and hip circumference. From this, waist-to-hip ratio will be calculated. Additionally, participants will be asked to use their own scales to provide their weight (if they don't have any they will be provided).
CGM: Participants will receive a continuous blood glucose monitor and be directed over teams how to fit this. One will be worn for two weeks in weeks 0 and 1 and another will be worn for two weeks in weeks 12 and 13.
Diet: Participants will receive a food diary to record their habitual dietary intake for three days (24 hours after the CGM is fitted). During the first week on the intervention they will also be asked to write down what they eat for lunch on the days they exercise.
Fitness test: Participants will receive a polar beat heart rate monitor. They will be asked to complete tthe harvard step test wearing the HR monitor at least 48 hours before they begin the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-60 years
- •BMI >28 kg.m-2
- •Not currently using any anti-diabetes medication
- •Physically inactive (performing less than two 30 min structured exercise sessions per week for the last year)
- •Not pregnant or currently breast feeding
- •Pre-menopausal or peri-menopausal
- •Not currently involved in a weight loss programme or using weight loss medication
排除标准
- •Involved in regular exercise (engaged in more than 3 sessions of structured exercise of >30 min per week)
- •Currently using anti-diabetes medication (e.g. insulin, metformin)
- •Pregnant or breast feeding
- •Currently engaged in active weight loss programme or using weight loss medication
- •Diagnosed with chronic kidney disease
- •Post-menopausal
结局指标
主要结局
Compliance
时间窗: HR and duration are measured during every exercise session to calculate this. There are 4 exercise sessions prescribed per week for 12 weeks.
Do participants complete each exercise session as prescribed?
Adhearance
时间窗: Number of exercise sessions are counted. There are 4 exercise sessions prescribed per week for 12 weeks.
Do individuals complete all the exercise sessions.
次要结局
- Time in Range for Plasma Glucose(Days 0 - 14 and days 77 - 91)
- HbA1c(0 and 12 weeks.)
- Hip Circumference(0 and 12-weeks.)
- Waist circumference(0 and 12 weeks.)
- Alanine Transferase(0 and 12-weeks.)