NCT02048839已完成不适用
Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- Type 2 Diabetes
研究概览
简要总结
SUBJECTS:
All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires
OVERALL OBJECTIVES:
- To determine the long-term effectiveness of a lifestyle intervention in high risk women and their offspring a in reducing the incidence of T2DM and cardiovascular disease and their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics markers .
- To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal a) glucose-insulin metabolism b) lipid metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later health outcomes in the mothers and their offspring.
- To study the association between gut microbiota and markers of offspring health
- To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
- To study the cost effectiveness of the intervention.
METHODS:
Maternal measurements
- Height, weight, waist and hip circumference
- Blood pressure, pulse
- Body fat percentage
- Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
- Fecal and hair samples
- Diurnal salivary cortisol assessment
- Background questionnaire: socioeconomic and health-related background
- Health-related quality of life (15-D).
- 3-day food diary and exercise diary
- ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
- Psychological questionnaires
- Pulse wave velocity (PWV) will be assessed
- Advanced glycation endproducts - a marker of cardiovascular health will be assessed
- Dental and oral health
- Bone health
- VHRU of arterial structure
Paternal measurements
- Background questionnaire (incl. height, weight, age)
- DNA-sample (buccal)
- 3-day food diary
- Psychological questionnaires
- Physical activity questionnaire (12 months)
Measurements of children
- Body weight, height, blood pressure, pulse
- Body fat percentage
- Psychological questionnaires
- Food and physical activities diaries
- ActiGraph, assessment of physical activity and sleep for 7 days
- Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
- Fecal, urine and hair samples
- A copy of child welfare center card (e.g. data on growth, immunizations, health)
- Endothelial function and pulse wave velocity (PWV)
- Bone health with peripheral CT
- Heart structure and function
- VHRU of arterial structure
TIMETABLE
Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017 and results will be reported from 2018 onwards in international peer-reviewed journals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all study subjects form Radiel intervention study, who delivered a baby
排除标准
- 未提供
结局指标
主要结局
Type 2 Diabetes
时间窗: 3-5 years post partum
次要结局
- Metabolic syndrome and cardiovascular morbidity(3-5 years post partum)
研究者
Saila Koivusalo
MD PhD
Helsinki University Central Hospital
研究点 (1)
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