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Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)

Not Applicable
Active, not recruiting
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

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

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Plasma glucose concentration
Secondary Outcome Measures
NameTimeMethod
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
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