NCT04585581Active, not recruitingNot Applicable
Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health
Norwegian University of Science and Technology1 site in 1 country167 target enrollmentStarted: November 6, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 167
- Locations
- 1
- Primary Endpoint
- Plasma glucose concentration
Study Overview
Brief Summary
The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.
Detailed Description
Women who are planning a pregnancy will be recruited into a parallel groups randomised controlled trial where the intervention will consist of high intensity training and time-restricted eating. The intervention will continue throughout pregnancy. The investigators will assess whether this lifestyle intervention can effect maternal and offspring cardiometabolic health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •contemplating pregnancy within the next six months
- •At least one of the following criteria: BMI ≥ 25 < 40 kg/m2, gestational diabetes in a previous pregnancy, previous infant > 4.5 kg, fasting plasma glucose > 5.3 mmol/L, or Non-European ethnicity
Exclusion Criteria
- •On-going pregnancy
- •Trying to conceive ≥ 6 cycles at study entry
- •Known diabetes (type 1 or 2)
- •Shift work that includes night shifts > 2 days per week
- •Previous hyperemesis
- •Known cardiovascular diseases
- •High intensity exercise ≥ 2 hours/week the last 3 months
- •Habitual eating window ≤ 12 hours
Outcomes
Primary Outcomes
Plasma glucose concentration
Time Frame: Gestational week 28
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Secondary Outcomes
- Head circumference of infant(Delivery)
- Fat mass(Baseline, intervention week 8, gestational week 12 and 28)
- Measured physical activity(From baseline and throughout the study period.)
- Plasma glucose concentration(Gestational week 12)
- HbA1c(Baseline, intervention week 8, gestational week 12 and 28)
- Glucose(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Diet intake(Every 8 week throughout the trial.)
- Insulin(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Cytokines(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Total cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Triglycerides(Baseline, intervention week 8, gestational week 12 and 28)
- Infant bone mass(Within 72 hours of birth and after 6 weeks post delivery)
- High density lipoprotein cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Low density lipoprotein cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Low density cholesterol(Baseline, intervention week 8, gestational week 12 and 28)
- Psychological general well being(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
- Time to pregnancy(From baseline to pregnancy (up to 36 weeks from enrollment))
- Birth weight (infant)(Delivery)
- Blood pressure (Infant)(Within 72 hours of birth and after 6 weeks post delivery)
- Homocysteine(Baseline, intervention week 8, gestational week 12 and 28)
- Continuous glucose monitoring(Baseline and 8 weeks intervention)
- Chronotype(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
- Apgar score(Delivery, after 1, 5 and 10 minutes)
- ICU admission(Delivery)
- Infant muscle mass(Within 72 hours of birth and after 6 weeks post delivery)
- Insulin sensitivity(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Muscle mass(Baseline, intervention week 8, gestational week 12 and 28)
- Psychological well-being(Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.)
- Cardiac function (Infant)(Within 72 hours of birth and after 6 weeks post delivery)
- Adipokines (Adiponectin, Leptin, Ghrelin)(Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery))
- Blood pressure(Baseline, intervention week 8, gestational week 12 and 28)
- Birth length (infant)(Delivery)
- Congenital malformation(Delivery)
- Gestational age at birth(Delivery)
- Length of stay at hospital(Delivery)
- Infant total body mass(Within 72 hours of birth and after 6 weeks post delivery)
- Infant fat mass(Within 72 hours of birth and after 6 weeks post delivery)
- Infant hydration status(Within 72 hours of birth and after 6 weeks post delivery)
- Total body mass(Baseline, intervention week 8, gestational week 12 and 28)
- Visceral fat area(Baseline, intervention week 8, gestational week 12 and 28)
- Cardiorespiratory fitness(Baseline and intervention week 8)
- Self-reported physical activity(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
- Sleep(Baseline, intervention week 8, gestational week 12 and 28, and every 8 week until delivery or until the participant is excluded from the trial due to not conceiving within 6 months from baseline)
Investigators
Study Sites (1)
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