Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes (TRE-HIIT Moms)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Peak oxygen uptake
研究概览
简要总结
This trial will recruit participants who had gestational diabetes in their most previous pregnancy. Participants will be randomly allocated into two groups: one intervention group and one control group 6-12 weeks after giving birth. The intervention group will undergo an 8-week supervised intervention consisting of time-restricted eating and endurance exercise training with moderate-to-high intensity. The investigators will assess cardiorespiratory fitness, body composition, and other markers of cardiovascular and metabolic health before and after the 8 weeks. Additionally, the participants in the intervention group will be encouraged to continue exercising and eating time restricted after the supervised period and follow them up by telephone until one year from the baseline visit. The investigators will measure the same outcomes at the follow-up as on the previous two test points.
详细描述
TREHIIT Moms is a randomised, controlled trial with two parallel groups. To be eligible for the trial, the participants need to have had gestational diabetes in their most previous pregnancy and be 6-12 weeks postpartum at inclusion. Participants will be randomly allocated to intervention or control (1:1). The intervention consist of time-restricted eating and endurance exercise. Time-restricted eating implies restricting energy intake to a maximum 10-hour time window daily. The exercise training will be supervised and consist of 2-4 weekly sessions of moderate-to-high intensity exercise. After the supervised period, the participants will continue high-intensity exercise and time-restricted eating at home, with follow-up from the researchers until 1 year from baseline.
The investigators will assess cardiometabolic health outcomes and psychological well-being at baseline, after 8 weeks, and 1 year. Human milk samples will be collected at baseline and 8 weeks and stored for future exploratory analyses of milk composition. The specific analytes and analytical methods will be determined in subsequent exploratory studies and are not prespecified trial outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational diabetes mellitus in most recent pregnancy
- •Within 6-12 weeks postpartum
- •Understands oral and written Norwegian or English
- •Able to walk or run on a treadmill or ride a bike for at least 60 minutes
- •Living in the Trondheim area
排除标准
- •Pregnant or trying to become pregnant
- •Diagnosed with type 1 or type 2 diabetes
- •Diagnosed with cardiovascular disease
- •Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
- •Habitual eating window of less than 12 hours/day
- •Engaging in regular high-intensity endurance training (once per week or more)
- •Intention of starting an exercise programme and/or a dietary strategy within the study period
- •Shift work that includes night shifts
- •Bariatric surgery
- •Any other reason which, according to the researchers, makes the potential participant ineligible
结局指标
主要结局
Peak oxygen uptake
时间窗: From baseline to after 8 weeks
Direct measurement of oxygen uptake during graded maximal exercise test to exhaustion
次要结局
- Muscle mass(From baseline to after 8 weeks)
- Peak oxygen uptake(From baseline to after 12 months)
- Body mass(From baseline to after 8 weeks)
- Body mass(From baseline to after 12 months)
- Fat mass(From baseline to after 8 weeks)
- Fat mass(From baseline to after 12 months)
- Muscle mass(From baseline to after 12 months)
- Visceral fat area(From baseline to after 8 weeks)
- Visceral fat area(From baseline to after 12 months)
- Bone mass(From baseline to after 8 weeks)
- Bone mass(From baseline to after 12 months)
- Waist circumference(From baseline to after 8 weeks)
- Waist circumference(From baseline to after 12 months)
- Systolic blood pressure(From baseline to after 8 weeks)
- Systolic blood pressure(From baseline to after 12 months)
- Diastolic blood pressure(From baseline to after 8 weeks)
- Diastolic blood pressure(From baseline to after 12 months)
- Resting heart rate(From baseline to after 8 weeks)
- Resting heart rate(From baseline to after 12 months)
- Blood cholesterol(From baseline to after 8 weeks)
- Blood cholesterol(From baseline to after 12 months)
- LDL cholesterol(From baseline to after 8 weeks)
- LDL cholesterol(From baseline to after 12 months)
- HDL cholesterol(From baseline to after 8 weeks)
- HDL cholesterol(From baseline to after 12 months)
- Triglycerides(From baseline to after 8 weeks)
- Triglycerides(From baseline to after 12 months)
- Fasting glucose(From baseline to after 8 weeks)
- Fasting glucose(From baseline to after 12 months)
- Insulin C-peptide(From baseline to after 8 weeks)
- Insulin C-peptide(From baseline to after 12 months)
- Plasma glucose after oral glucose tolerance test(From baseline to after 8 weeks)
- Plasma glucose after oral glucose tolerance test(From baseline to after 12 months)
- Dietary intake(From baseline to after 8 weeks)
- Dietary intake(From baseline to after 12 months)
- Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer(From baseline to after 8 weeks)
- Mean Daily Minutes of Moderate-to-Vigorous Physical Activity Measured by ActiGraph Accelerometer(From baseline to after 12 months)
- Self-reported physical activity(From baseline to after 8 weeks)
- Self-reported physical activity(From baseline to after 12 months)
- Psychological wellbeing(From baseline to after 8 weeks)
- Psychological wellbeing(From baseline to after 12 months)
- Sleep quality(From baseline to after 8 weeks)
- Sleep quality(From baseline to after 12 months)
- Depression(From baseline to 8 weeks)
- Depression(From baseline to after 12 months)
- Anxiety(From baseline to after 8 weeks)
- Anxiety(From baseline to after 12 months)
- Type 2 diabetes mellitus diagnosis(During the 12-month follow-up)
- Mean Daily Step Count Measured by ActiGraph Accelerometer(From baseline to after 8 weeks)
- Mean Daily Sedentary Time Measured by ActiGraph Accelerometer(At baseline and after 8 weeks)
- Mean Daily Step Count Measured by ActiGraph Accelerometer(From baseline to after 12 months)
- Mean Daily Sedentary Time Measured by ActiGraph Accelerometer(From baseline to after 12 months)