A Novel Diet Approach to Combat Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Weekly adherence rates for time restricted eating (TRE)
研究概览
简要总结
There is an urgent need to implement novel diet approaches to combat the increasing rates of gestational diabetes mellitus (GDM). The primary aim of this study is to establish the feasibility of time-restricted eating in pregnancy, to prepare for future larger controlled trials in this research project to determine the efficacy of time-restricted eating in women at risk of GDM. Expectations:
- Women who have an increased risk of GDM will be able to adhere to time reduced eating during pregnancy.
- Time reduced eating will improve short-term glycemic control in pregnancy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •carrying one singleton live foetus
- •in pregnancy week 12-30
- •having at least one risk factor for gestational diabetes mellitus (GDM) according to Norwegian guidelines for GDM screening: pre-pregnancy BMI > 25 kg/m2, GDM in previous pregnancy, primiparae aged > 25 years, first degree relative with diabetes mellitus, Asian or African ethnicity, previous delivery of new-born > 4.5 kg
- •understand written and spoken Norwegian language
排除标准
- •habitual eating window < 12 hours
结局指标
主要结局
Weekly adherence rates for time restricted eating (TRE)
时间窗: Weekly measures throughout the 5 week period of TRE intervention
The number of days per week that the participants are able to adhere to TRE, as calculated as weekly average of days with a time-window ≤ 10 hours
Change in average time-window for energy intake
时间窗: Change between baseline (pre-intervention) time-window for energy intake to average time-window for energy intake during the 5-week intervention period
Average daily time-window for energy intake will be registered through log books.
次要结局
- Change between baseline and post-intervention in fasting glucose(6 weeks)
- Change in triglycerides(6 weeks)
- Change in LDL cholesterol(6 weeks)
- Change in HbA1c(6 weeks)
- Continuous glucose monitoring(6 weeks)
- Change between baseline and post-intervention muscle mass(6 weeks)
- Perceived barriers to the protocol assessed with an unstructured interview(Weekly phone calls to participants in TRE group during the 5-week intervention period and after 6 weeks)
- Change between baseline and post-intervention in postprandial glucose(6 weeks)
- Change between baseline and post-intervention in fasting insulin(6 weeks)
- Change between baseline and post-intervention in postprandial insulin(6 weeks)
- Change between baseline and post-intervention blood pressure(6 weeks)
- Change in total cholesterol(6 weeks)
- Change in HDL cholesterol(6 weeks)
- Change between baseline and post-intervention visceral fat area(6 weeks)
- Subjective appetite sensations assessed by Visual Analogue Scales(Once weekly throughout 6 weeks, on a weekday.)
- Change between baseline and post-intervention body mass(6 weeks)
- Change between baseline and post-intervention fat mass(6 weeks)