Clinical trial NCT04585581: Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)
Official title: Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Keywords: Diet therapy
Exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2020-10-14
Enrollment: 167
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma glucose concentration
timeFrame: Gestational week 28
Secondary outcomes:
measure: Plasma glucose concentration
timeFrame: Gestational week 12
measure: HbA1c
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Total cholesterol
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Triglycerides
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: High density lipoprotein cholesterol
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Low density lipoprotein cholesterol
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Low density cholesterol
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Glucose
timeFrame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
measure: Insulin
timeFrame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
measure: Cytokines
timeFrame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
measure: Adipokines (Adiponectin, Leptin, Ghrelin)
timeFrame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
measure: Homocysteine
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Insulin sensitivity
timeFrame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
measure: Total body mass
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Fat mass
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Muscle mass
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Visceral fat area
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Continuous glucose monitoring
timeFrame: Baseline and 8 weeks intervention
measure: Cardiorespiratory fitness
timeFrame: Baseline and intervention week 8
measure: Blood pressure
timeFrame: Baseline, intervention week 8, gestational week 12 and 28
measure: Measured physical activity
timeFrame: Baseline
measure: Measured physical activity
timeFrame: From baseline and throughout the study period.
measure: Diet intake
timeFrame: Every 8 week throughout the trial.
measure: Self-reported physical activity
timeFrame: 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
measure: Sleep
timeFrame: 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
measure: Chronotype
timeFrame: 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
measure: Psychological general well being
timeFrame: 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
measure: Time to pregnancy
timeFrame: From baseline to pregnancy (up to 36 weeks from enrollment)
measure: Psychological well-being
timeFrame: Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.
measure: Birth weight (infant)
timeFrame: Delivery
measure: Birth length (infant)
timeFrame: Delivery
measure: Head circumference of infant
timeFrame: Delivery
measure: Apgar score
timeFrame: Delivery, after 1, 5 and 10 minutes
measure: ICU admission
timeFrame: Delivery
measure: Congenital malformation
timeFrame: Delivery
measure: Gestational age at birth
timeFrame: Delivery
measure: Length of stay at hospital
timeFrame: Delivery
measure: Blood pressure (Infant)
timeFrame: Within 72 hours of birth and after 6 weeks post delivery
measure: Cardiac function (Infant)
timeFrame: Within 72 hours of birth and after 6 weeks post delivery
measure: Infant total body mass
timeFrame: Within 72 hours of birth and after 6 weeks post delivery
measure: Infant muscle mass
timeFrame: Within 72 hours of birth and after 6 weeks post delivery
measure: Infant fat mass
timeFrame: Within 72 hours of birth and after 6 weeks post delivery
measure: Infant hydration status
timeFrame: Within 72 hours of birth and after 6 weeks post delivery
measure: Infant bone mass
timeFrame: Within 72 hours of birth and after 6 weeks post delivery
Other outcomes:
measure: Infant gut microbiome
timeFrame: Within one week of birth, after 6 weeks and after 6 months
measure: Maternal gut microbiome
timeFrame: After 6 weeks after delivery and after 6 months
measure: Breastmilk composition
timeFrame: After 6 weeks after delivery and after 6 months
measure: Infant total body mass
timeFrame: At age of 6 months
measure: Infant fat mass
timeFrame: At age of 6 months
measure: Infant muscle mass
timeFrame: At age of 6 months
measure: Infant hydration status
timeFrame: At age of 6 months
measure: Infant bone mass
timeFrame: At age of 6 months
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology, Fac MH ISB
name: Øystein Risa
role: STUDY_DIRECTOR
affiliation: St Olavs Hospital, Dept Obstetrics & Gynecology
name: Kjell Å Salvesen, md prof
role: STUDY_DIRECTOR
References: