Effects of Supervised Exercise During Gestation on Maternal and Foetal Health Markers. The GESTAFIT Project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- Universidad de Granada
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Investigators
Virginia A. Aparicio García-Molina
PhD
Universidad de Granada
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)
Time Frame: 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)
Time Frame: 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
Time Frame: At delivery in cord blood samples
Neonatal insulin sensitivity will be assessed through the ratio glucose/insulin.
Secondary Outcomes
- 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)