Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)
- Conditions
- Gestational Diabetes
- Registration Number
- NCT04585581
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 167
Inclusion Criteria:<br><br> - contemplating pregnancy within the next six months<br><br> - At least one of the following criteria: BMI = 25 < 40 kg/m2, gestational diabetes in<br> a previous pregnancy, previous infant > 4.5 kg, fasting plasma glucose > 5.3 mmol/L,<br> or Non-European ethnicity<br><br>Exclusion Criteria:<br><br> - On-going pregnancy<br><br> - Trying to conceive = 6 cycles at study entry<br><br> - Known diabetes (type 1 or 2)<br><br> - Shift work that includes night shifts > 2 days per week<br><br> - Previous hyperemesis<br><br> - Known cardiovascular diseases<br><br> - High intensity exercise = 2 hours/week the last 3 months<br><br> - Habitual eating window = 12 hours
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma glucose concentration
- Secondary Outcome Measures
Name Time Method Plasma glucose concentration;HbA1c;Total cholesterol;Triglycerides;High density lipoprotein cholesterol;Low density lipoprotein cholesterol;Low density cholesterol;Glucose;Insulin;Cytokines;Adipokines (Adiponectin, Leptin, Ghrelin);Homocysteine;Insulin sensitivity;Total body mass;Fat mass;Muscle mass;Visceral fat area;Continuous glucose monitoring;Cardiorespiratory fitness;Blood pressure;Measured physical activity;Measured physical activity;Diet intake;Self-reported physical activity;Sleep;Chronotype;Psychological general well being;Time to pregnancy;Psychological well-being;Birth weight (infant);Birth length (infant);Head circumference of infant;Apgar score;ICU admission;Congenital malformation;Gestational age at birth;Length of stay at hospital;Blood pressure (Infant);Cardiac function (Infant);Infant total body mass;Infant muscle mass;Infant fat mass;Infant hydration status;Infant bone mass