Effects of Time-restricted Eating and Interval Training With Digital Follow-up: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Total fat mass
研究概览
简要总结
This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). Before and after the intervention, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index ≥ 27 kg/m²
- •Able to walk or ride a bike > 60 min
排除标准
- •On-going pregnancy
- •Lactation within 24 weeks of study commencement
- •High-intensity exercise ≥ 1/week
- •Habitual eating window ≤12 hours/day
- •Taking hypertension, glucose-, or lipid-lowering drugs
- •Body mass variation ≥ 4 kg three months prior to study commencement
- •Known diabetes mellitus (type 1 or 2) or cardiovascular disease
- •Working night shifts
研究组 & 干预措施
Time-restricted eating and high-intensity interval training
Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up.
干预措施: Time-restricted eating and high-intensity interval training (Behavioral)
Control
No intervention nor digital follow-up for seven weeks.
结局指标
主要结局
Total fat mass
时间窗: From baseline to after 7 weeks of intervention
Change in total fat mass measured with bioelectrical impedance analysis
次要结局
- Average glucose levels(From baseline to after 7 weeks of intervention)
- Insulin sensitivity(From baseline to after 7 weeks of intervention)
- Diastolic blood pressure(From baseline to after 7 weeks of intervention)
- Insulin(From baseline to after 7 weeks of intervention)
- Systolic blood pressure(From baseline to after 7 weeks of intervention)
- Physical activity level(From baseline to after 7 weeks of intervention)
- Cardiorespiratory fitness(From baseline to after 7 weeks of intervention)
- Visceral fat area(From baseline to after 7 weeks of intervention)
- Sleep duration(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention)
- Blood glucose(From baseline to after 7 weeks of intervention)
- Blood Cholesterol(From baseline to after 7 weeks of intervention)
- HDL-cholesterol in blood(From baseline to after 7 weeks of intervention)
- Triglycerides in blood(From baseline to after 7 weeks of intervention)
- Body mass(From baseline to after 7 weeks of intervention)
- LDL-cholesterol in blood(From baseline to after 7 weeks of intervention)
- Body fat-free mass(From baseline to after 7 weeks of intervention)
- Resting heart rate(From baseline to after 7 weeks of intervention)
- Appetite(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention)
- Self-reported physical activity(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.)
- Diet intake(7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.)
- Sleep quality(From baseline to after 7 weeks of intervention)