Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 6
- 主要终点
- Child Body Mass Index (kg/m2), derived from weight and height
研究概览
简要总结
There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms.
This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms.
The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children still participating in the NiPPeR study at 6-8 years.
排除标准
- •Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.
结局指标
主要结局
Child Body Mass Index (kg/m2), derived from weight and height
时间窗: Up to age 8 years, from periconception to age 8 years
Child size and body composition
Strengths & Difficulties Questionnaire score (no units)
时间窗: Up to age 8 years, from periconception to age 8 years
Child neurobehavioural functioning
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
时间窗: Up to age 8 years, from periconception to age 8 years
Child cognition
Dimensional Change Card Sort Test (raw & T-scores)
时间窗: Up to age 8 years, from periconception to age 8 years
Child executive functioning - NIH Toolbox Cognition Battery component
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
时间窗: Up to age 8 years, from periconception to age 8 years
Child insulin resistance
Flanker Inhibitory Control & Attention Test (raw & T-scores)
时间窗: Up to age 8 years, from periconception to age 8 years
Child executive functioning - NIH Toolbox Cognition Battery Component
Child Behaviour Check List score (no units)
时间窗: Up to age 8 years, from periconception to age 8 years
Child neurobehavioural functioning
次要结局
- Change in lean mass (kg)(Up to age 8 years, from periconception to age 8 years)
- Body bone mass (kg, % and indices)(Up to age 8 years, from periconception to age 8 years)
- Child height (cm)(Up to age 8 years, from periconception to age 8 years)
- Change in weight (kg)(Up to age 8 years, from periconception to age 8 years)
- Body lean mass (kg, % and indices)(Up to age 8 years, from periconception to age 8 years)
- Change in body mass index (z-score & percentile)(Up to age 8 years, from periconception to age 8 years)
- Child mid-upper arm circumference (cm)(Up to age 8 years, from periconception to age 8 years)
- Change in waist circumference (z-score)(Up to age 8 years, from periconception to age 8 years)
- Heart rate response to step test (beats per minute)(Up to age 8 years, from periconception to age 8 years)
- Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing(Up to age 8 years, from periconception to age 8 years)
- Parental Feeding Practices Questionnaire(Up to age 8 years, from periconception to age 8 years)
- Hair metabolome panel concentrations (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Body fat mass (kg, % and indices)(Up to age 8 years, from periconception to age 8 years)
- Change in mid-upper circumference (z-score)(Up to age 8 years, from periconception to age 8 years)
- Child blood pressure (mm Hg)(Up to age 8 years, from periconception to age 8 years)
- Child resting heart rate (beats per minute)(Up to age 8 years, from periconception to age 8 years)
- Child Eating Behaviour Questionnaire(Up to age 8 years, from periconception to age 8 years)
- Children's Sleep Habits Questionnaire(Up to age 8 years, from periconception to age 8 years)
- Children's actigraphy measurements of activity behaviours [minutes/day](Up to age 8 years, from periconception to age 8 years)
- Skin pricks test results to allergens [mm](Up to age 8 years, from periconception to age 8 years)
- Change in body fat mass (kg)(Up to age 8 years, from periconception to age 8 years)
- Change in bone mass (kg)(Up to age 8 years, from periconception to age 8 years)
- Height growth (cm)(Up to age 8 years, from periconception to age 8 years)
- Child minutes to return to resting heart rate (minutes)(Up to age 8 years, from periconception to age 8 years)
- Stool metagenomic profile (abundance)(Up to age 8 years, from periconception to age 8 years)
- Skin metagenomic profile (abundance)(Up to age 8 years, from periconception to age 8 years)
- Buccal transcriptomic profile (relative expression)(Up to age 8 years, from periconception to age 8 years)
- Plasma high-sensitivity C-reactive protein concentrations (mmol/L)(Up to age 8 years, from periconception to age 8 years)
- Child waist circumference (cm)(Up to age 8 years, from periconception to age 8 years)
- Dietary patterns ascertained by frequency questionnaires(Up to age 8 years, from periconception to age 8 years)
- Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires(Up to age 8 years, from periconception to age 8 years)
- Urine micronutrient concentrations (nmol/L)(Up to age 8 years, from periconception to age 8 years)
- Blood trace element concentrations (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Blood molecular profile (% methylation)(Up to age 8 years, from periconception to age 8 years)
- Plasma glucose concentration (mmol/L)(Up to age 8 years, from periconception to age 8 years)
- Blood metabolome panel concentrations (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Child Movement Behaviour Questionnaire(Up to age 8 years, from periconception to age 8 years)
- Urine trace element concentrations (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Genetic variation (DNA sequence analysis)(Up to age 8 years, from periconception to age 8 years)
- Circulating adipokine measurements (nmol/L)(Up to age 8 years, from periconception to age 8 years)
- Circulating inflammatory marker measurement (nmol/L)(Up to age 8 years, from periconception to age 8 years)
- Urine metabolome panel concentrations (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Urine measurement of environmental pollutant exposure (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Hair measurement of environmental pollutant exposure (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Blood micronutrient concentrations (nmol/L)(Up to age 8 years, from periconception to age 8 years)
- Stool metatranscriptomic profile (relative activity)(Up to age 8 years, from periconception to age 8 years)
- Skin metatranscriptomic profile (relative activity)(Up to age 8 years, from periconception to age 8 years)
- Skin metabolomic profile (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Buccal molecular profile (% methylation)(Up to age 8 years, from periconception to age 8 years)
- Blood transcriptomic profile (relative expression)(Up to age 8 years, from periconception to age 8 years)
- Plasma lipid concentrations (mmol/L)(Up to age 8 years, from periconception to age 8 years)
- Blood measurement of environmental pollutant exposure (ng/gm lipid)(Up to age 8 years, from periconception to age 8 years)
- Stool metabolomic profile (pmol/L)(Up to age 8 years, from periconception to age 8 years)
- Circulating chemocytokine measurements (nmol/L)(Up to age 8 years, from periconception to age 8 years)