Effects of Supervised Exercise During Gestation on Maternal and Foetal Health Markers. The GESTAFIT Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)
研究概览
简要总结
The main objective of this project is to assess the effects of a novel and supervised exercise intervention in overweight pregnant and their newborn.
Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant interested in participate in the intervention program will be randomly assigned to either exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii) physical fitness; iv) objectively measured physical activity and sedentary behaviour; v) sleep quality; vi) mental health, quality of life and positive health; vii) haematology and biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an intention-to-treat basis and per protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gestafitos
This is a longitudinal study developed, which is the continuation of the GESTAtion and FITness (GESTAFIT) Project. The main purpose is to evaluate the influence of a concurrent physical exercise program during pregnancy (developed under the GESTAFIT project) on the body composition, physical fitness, brain structure, and motor, cognitive, and language development of the offspring at four years of age.
干预措施: Exercise intervention (Other)
Gestafitos
This is a longitudinal study developed, which is the continuation of the GESTAtion and FITness (GESTAFIT) Project. The main purpose is to evaluate the influence of a concurrent physical exercise program during pregnancy (developed under the GESTAFIT project) on the body composition, physical fitness, brain structure, and motor, cognitive, and language development of the offspring at four years of age.
干预措施: Control group (Other)
Placentraining
This is a retrospective study which purpose is to analyse the status of placentas of women participating in the GESTAFIT project, in which a concurrent physical exercise programme was developed. This rigorous design will allow us to test our central hypothesis that exercise during pregnancy will produce greater improvements in placental metabolic pathways associated with pregnancy complications, and is associated with better pregnancy and newborn outcomes.
干预措施: Exercise intervention (Other)
Placentraining
This is a retrospective study which purpose is to analyse the status of placentas of women participating in the GESTAFIT project, in which a concurrent physical exercise programme was developed. This rigorous design will allow us to test our central hypothesis that exercise during pregnancy will produce greater improvements in placental metabolic pathways associated with pregnancy complications, and is associated with better pregnancy and newborn outcomes.
干预措施: Control group (Other)
结局指标
主要结局
Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)
时间窗: 34th week of gestation
Insulin sensitivity will be derived from the homeostatic model assessment for insulin resistance (HOMA-IR), which will be calculated using the formula \[fasting insulin (μIU/mL) x fasting glucose (mg/dL)\]/405.
Maternal weight gain (kg)
时间窗: 34th week of gestation
Maternal weight gain will be defined as the weight change from baseline measurement to the last measurement
Neonatal insuline-glucose index
时间窗: At delivery in cord blood samples
Neonatal insulin sensitivity will be assessed through the ratio glucose/insulin.
次要结局
- Sleep behaviours (through accelerometry)(at the 16th, 24th and 34th week of gestation)
- Insomnia Symptoms Questionnaire(at the 16th, 24th and 34th week of gestation)
- Quality of life (Short-Form Health Survey 36)(at the 16th and 34th week of gestation)
- 6-item Female Sexual Function Index(at the 16th and 34th week of gestation)
- Positive health(at the 16th and 34th week of gestation)
- Haematology(at 34th week of gestation and at delivery)
- Lipid profile (in mother and cord blood)(at 34th week of gestation and at delivery)
- Glycaemic profile (in mother and cord blood)(at 34th week of gestation and at delivery)
- Total plasma antioxidant capacity (in mother and cord blood)(at 34th week of gestation and at delivery)
- Plasma liposoluble antioxidants (in mother and cord blood)(at 34th week of gestation and at delivery)
- Antioxidant enzymes activity (in mother and cord blood)(at 34th week of gestation and at delivery)
- Carbonyl proteins (in mother and cord blood)(at 34th week of gestation and at delivery)
- Oxidative damage to lipids (in mother and cord blood)(at 34th week of gestation and at delivery)
- Resting heart rate (bpm)(at the 16th and 34th week of gestation)
- Cardiorespiratory fitness (meters in the 6-min walk test)(at the 16th and 34th week of gestation)
- Adiposity-related proteins expression (in mother and cord blood)(At delivery)
- Anthropometry and Body Composition of the Mother and Child (Gestafitos)(4 ± 1 years after birth)
- Blood Pressure and Resting Heart Rate of the Mother and Child (Gestafitos)(4 ± 1 years after birth)
- Nutritional Status of the Mother and Child (Gestafitos)(4 ± 1 years after birth)
- Physical Activity, Sedentary Behavior, and Sleep Quality of the Mother and Child(4 ± 1 years after birth)
- Health-Related Physical Fitness of the Child: PREFIT Battery(4 ± 1 years after birth)
- Brain Structure, Cerebral Blood Flow, and Brain Function via Structural and Functional Magnetic Resonance Imaging (Gestafitos)(4 ± 1 years after birth)
- Cognition (Gestafitos)(4 ± 1 years after birth)
- Academic Performance (Gestafitos)(4 ± 1 years after birth)
- Genetic and Epigenetic Analyses (Gestafitos)(4 ± 1 years after birth)
- Expression of markers of biogenesis, autophagy, mitochondrial fusion-fission processes (Placentraining)(after placental expulsion following birth)
- Trace and ultra-trace minerals (Placentraining)(after placental expulsion following birth)
- Genomic and methylation (Placentraining)(after placental expulsion following birth)
- Candidate gene expression and Small RNA analysis (Placentraining)(after placental expulsion following birth)
- Targeted and untargeted metabolomics and lipidomics analyses(after placental expulsion following birth)
- Toxics (Placentraining)(after placental expulsion following birth)
- Inflammatory, anti-inflammatory, vasculogenesis and angiogenesis markers (Placentraining)(after placental expulsion following birth)
- Systolic and diastolic blood pressure (mmHg)(at the 16th and 34th week of gestation)
- Resting heart rate (bpm)(at the 16th and 34th week of gestation)
- The Mediterranean Diet Score(at the 16th and 34th week of gestation)
- Cardiorespiratory fitness (Vo2max)(at the 16th and 34th week of gestation)
- Cardiorespiratory fitness (meters in the 6-min walk test)(at the 16th and 34th week of gestation)
- Muscle strength (kg)(at the 16th and 34th week of gestation)
- Flexibility (cm)(at the 16th and 34th week of gestation)
- Physical activity and sedentary behaviour (in minutes)(at the 16th, 24th and 34th week of gestation)
- Sleep behaviours (through accelerometry)(at the 16th, 24th and 34th week of gestation)
- Pittsburgh Sleep Quality Index(at the 16th, 24th and 34th week of gestation)
- Insomnia Symptoms Questionnaire(at the 16th, 24th and 34th week of gestation)
- Quality of life (Short-Form Health Survey 36)(at the 16th and 34th week of gestation)
- Epidemiological Studies-Depression Scale questionnaire(at the 16th and 34th week of gestation)
- State Trait Anxiety Index.(at the 16th and 34th week of gestation)
- The Detention of Restless Legs Syndrome questionnaire(at the 16th and 34th week of gestation)
- Oswestry Disability Index score(at the 16th and 34th week of gestation)
- Pain Visual Analogue Scale(at the 16th and 34th week of gestation)
- 6-item Female Sexual Function Index(at the 16th and 34th week of gestation)
- Positive health(at the 16th and 34th week of gestation)
- Haematology(at 34th week of gestation and at delivery)
- Lipid profile (in mother and cord blood)(at 34th week of gestation and at delivery)
- Glycaemic profile (in mother and cord blood)(at 34th week of gestation and at delivery)
- Total plasma antioxidant capacity (in mother and cord blood)(at 34th week of gestation and at delivery)
- Plasma liposoluble antioxidants (in mother and cord blood)(at 34th week of gestation and at delivery)
- Antioxidant enzymes activity (in mother and cord blood)(at 34th week of gestation and at delivery)
- Carbonyl proteins (in mother and cord blood)(at 34th week of gestation and at delivery)
- Oxidative damage to lipids (in mother and cord blood)(at 34th week of gestation and at delivery)
- Oxidative damage to DNA (in mother and cord blood)(at 34th week of gestation and at delivery)
- Pro- and anti-inflammatory signal (in mother and cord blood)(at 34th week of gestation and at delivery)
- Bone biomarkers (in mother and cord blood)(at 34th week of gestation and at delivery)
- Adiposity-related proteins expression (in mother and cord blood)(At delivery)
- Anthropometry and Body Composition of the Mother and Child (Gestafitos)(4 ± 1 years after birth)
- Blood Pressure and Resting Heart Rate of the Mother and Child (Gestafitos)(4 ± 1 years after birth)
- Nutritional Status of the Mother and Child (Gestafitos)(4 ± 1 years after birth)
- Physical Activity, Sedentary Behavior, and Sleep Quality of the Mother and Child(4 ± 1 years after birth)
- Health-Related Physical Fitness of the Child: PREFIT Battery(4 ± 1 years after birth)
- Brain Structure, Cerebral Blood Flow, and Brain Function via Structural and Functional Magnetic Resonance Imaging (Gestafitos)(4 ± 1 years after birth)
- Cognition (Gestafitos)(4 ± 1 years after birth)
- Academic Performance (Gestafitos)(4 ± 1 years after birth)
- Genetic and Epigenetic Analyses (Gestafitos)(4 ± 1 years after birth)
- Oxidative stress and antioxidant defence (Placentraining)(after placental expulsion following birth)
- Expression of markers of biogenesis, autophagy, mitochondrial fusion-fission processes (Placentraining)(after placental expulsion following birth)
- Trace and ultra-trace minerals (Placentraining)(after placental expulsion following birth)
- Genomic and methylation (Placentraining)(after placental expulsion following birth)
- Candidate gene expression and Small RNA analysis (Placentraining)(after placental expulsion following birth)
- Targeted and untargeted metabolomics and lipidomics analyses(after placental expulsion following birth)
- Toxics (Placentraining)(after placental expulsion following birth)
- Inflammatory, anti-inflammatory, vasculogenesis and angiogenesis markers (Placentraining)(after placental expulsion following birth)
研究者
Virginia A. Aparicio García-Molina
PhD
Universidad de Granada