Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)
- Conditions
- Gestational Diabetes
- Interventions
- Behavioral: time-restricted eatingBehavioral: high intensity exerciseOther: Standard Care
- Registration Number
- NCT04585581
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 167
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description diet + training Standard Care - diet + training time-restricted eating - controls Standard Care - diet + training high intensity exercise -
- Primary Outcome Measures
Name Time Method Plasma glucose concentration Gestational week 28 Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
- Secondary Outcome Measures
Name Time Method Plasma glucose concentration Gestational week 12 Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
HbA1c Baseline, intervention week 8, gestational week 12 and 28 Measured in the maternal blood
Glucose Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) Measured in the blood
Insulin Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) Measured in the blood
Cytokines Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) Measured in the blood, a panel of 27 cytokines of relevance for inflammatory status (Bio-Plex Pro Human Cytokine 27-plex Assay)
Total cholesterol Baseline, intervention week 8, gestational week 12 and 28 Measured in the maternal blood
Triglycerides Baseline, intervention week 8, gestational week 12 and 28 Measured in the maternal blood
Fat mass Baseline, intervention week 8, gestational week 12 and 28 Estimated using InBody720 bioimpedance scale.
Measured physical activity From baseline and throughout the study period. Measured by Amazfit GTS smartwatch
Diet intake Every 8 week throughout the trial. Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays=
High density lipoprotein cholesterol Baseline, intervention week 8, gestational week 12 and 28 Measured in the maternal blood
Low density lipoprotein cholesterol Baseline, intervention week 8, gestational week 12 and 28 Measured in the maternal blood
Low density cholesterol Baseline, intervention week 8, gestational week 12 and 28 Measured in the maternal blood
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 Psychological general well being index (PGWBI)
Time to pregnancy From baseline to pregnancy (up to 36 weeks from enrollment) Self-reported
Birth weight (infant) Delivery From hospital record
Blood pressure (Infant) Within 72 hours of birth and after 6 weeks post delivery Blood pressure (systolic - and diastolic)
Homocysteine Baseline, intervention week 8, gestational week 12 and 28 Measured in the maternal blood
Continuous glucose monitoring Baseline and 8 weeks intervention Continuous glucose monitoring using Freestyle Libre (Abbott Diabetes Care), worn for 14 days.
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 Self-reported: Hornestberg Morningness Eveningness Questionnaire
Apgar score Delivery, after 1, 5 and 10 minutes From hospital record
ICU admission Delivery From hospital record
Infant muscle mass Within 72 hours of birth and after 6 weeks post delivery Estimated using impedance measurements (BioScan tough i8-nano)
Infant bone mass Within 72 hours of birth and after 6 weeks post delivery Estimated using impedance measurements (BioScan tough i8-nano)
Insulin sensitivity Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5)
Muscle mass Baseline, intervention week 8, gestational week 12 and 28 Estimated using InBody720 bioimpedance scale.
Psychological well-being Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial. Self-reported: Psychological General Well Being Index
Head circumference of infant Delivery From hospital record
Cardiac function (Infant) Within 72 hours of birth and after 6 weeks post delivery Ultrasound echocardiography
Blood flow and myocardial function will be measured using mechanical wave imaging (MWI).Adipokines (Adiponectin, Leptin, Ghrelin) Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) Measured in the maternal blood
Blood pressure Baseline, intervention week 8, gestational week 12 and 28 Systolic - and diastolic blood pressure (in mmHg) will be measured in the seated position after 15 minutes of rest with an automatic blood pressure device (Welch Allyn, Germany) three times with one minute intervals, in left arm (average of three measurement).
Birth length (infant) Delivery From hospital record
Congenital malformation Delivery From hospital record
Gestational age at birth Delivery From hospital record
Length of stay at hospital Delivery From hospital record
Infant total body mass Within 72 hours of birth and after 6 weeks post delivery Estimated using impedance measurements (BioScan tough i8-nano)
Infant fat mass Within 72 hours of birth and after 6 weeks post delivery Estimated using impedance measurements (BioScan tough i8-nano)
Infant hydration status Within 72 hours of birth and after 6 weeks post delivery Estimated using impedance measurements (BioScan tough i8-nano)
Total body mass Baseline, intervention week 8, gestational week 12 and 28 Estimated using InBody720 bioimpedance scale.
Visceral fat area Baseline, intervention week 8, gestational week 12 and 28 Estimated using InBody720 bioimpedance scale.
Cardiorespiratory fitness Baseline and intervention week 8 Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer.
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 International Physical Activity Questionnaire
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 Self-reported: Pittsburgh Sleep Quality Index
Trial Locations
- Locations (1)
St Olavs Hospital
🇳🇴Trondheim, Norway