NCT02617693已完成4 期
Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 2
- 主要终点
- Difference in waist circumference
研究概览
简要总结
This study is conducted in Asia. The aim of this study is to assess the efficacy of a pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Nulliparity
- •Not pregnant at the time of signing informed consent
- •Own a smartphone with either Android system version 4.1 and above or iOS system 7.0 and above with internet access
排除标准
- •Female subject undergoing treatment for type 1 or 2 diabetes mellitus
- •Subjects not residing in the district of Seremban
研究组 & 干预措施
Standard of care
Other
干预措施: standard antenatal care (Other)
Life style intervention
Experimental
干预措施: lifestyle intervention (Behavioral)
结局指标
主要结局
Difference in waist circumference
时间窗: Months 0-8
次要结局
- Change in HbA1c (Glycosylated haemoglobin))(Month 0, Month 8)
- Change in BMI (Body Mass Index)(Month 0, Month 8)
- Change in waist-to-height ratio (WHtR)(Month 0, Month 8)
- Change in waist-to-hip ratio(Month 0, Month 8)
- Change in weight(Month 0, Month 8)
- Change in physical activity and sedentary behaviour, as measured by the International Physical Activity Questionnaire (IPAQ) used in National Health Surveys in Malaysia(Month 0, Month 8)
- Change in stress levels, as measured by the Depression Anxiety and Stress Scale 21-items (DASS-21) used in National Health Surveys in Malaysia(Month 0, Month 8)
- Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)(Month 0, Month 8)
- Change in the fasting lipid profile (total cholesterol [TC], low density lipoprotein cholesterol[LDL-C], high density lipoprotein cholesterol[HDL-C], triglycerides [TG])(Month 0, Month 8)
- Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))(Month 0, Month 8)
- Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)(Month 0, Month 8)
- Change in dietary intake, as measured by the Frequency Food Questionnaire (FFQ) that is used in National Health Surveys in Malaysia(Month 0, Month 8)
研究者
研究点 (2)
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