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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Behavioral: time-restricted eating
* Behavioral: high intensity exercise
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet + training<br> | Behavioral: time-restricted eating<br>* Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.<br>Behavioral: high intensity exercise<br>* Participants will be encouraged to exercise with high intensity 2-3 times per week<br>Other: Standard Care<br>* Standard clinical care<br>|
| Active Comparator: controls<br> | Other: Standard Care<br>* Standard clinical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose concentration | Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose) | Gestational week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose concentration | Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose) | Gestational week 12 | 
| HbA1c | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28 | 
| Total cholesterol | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28 | 
| Triglycerides | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28 | 
| High density lipoprotein cholesterol | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28 | 
| Low density lipoprotein cholesterol | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28 | 
| Low density cholesterol | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28 | 
| Glucose | Measured in the blood | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | 
| Insulin | Measured in the blood | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | 
| Cytokines | Measured in the blood, a panel of 27 cytokines of relevance for inflammatory status (Bio-Plex Pro Human Cytokine 27-plex Assay) | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | 
| Adipokines (Adiponectin, Leptin, Ghrelin) | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | 
| Homocysteine | Measured in the maternal blood | Baseline, intervention week 8, gestational week 12 and 28 | 
| Insulin sensitivity | 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) | Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery) | 
| Total body mass | Estimated using InBody720 bioimpedance scale. | Baseline, intervention week 8, gestational week 12 and 28 | 
| Fat mass | Estimated using InBody720 bioimpedance scale. | Baseline, intervention week 8, gestational week 12 and 28 | 
| Muscle mass | Estimated using InBody720 bioimpedance scale. | Baseline, intervention week 8, gestational week 12 and 28 | 
| Visceral fat area | Estimated using InBody720 bioimpedance scale. | Baseline, intervention week 8, gestational week 12 and 28 | 
| Continuous glucose monitoring | Continuous glucose monitoring using Freestyle Libre (Abbott Diabetes Care), worn for 14 days. | Baseline and 8 weeks intervention | 
| Cardiorespiratory fitness | Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer. | Baseline and intervention week 8 | 
| Blood pressure | 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). | Baseline, intervention week 8, gestational week 12 and 28 | 
| Measured physical activity | Measured by SenseWear activity monitor, worn for 7 days. | Baseline | 
| Measured physical activity | Measured by Amazfit GTS smartwatch | From baseline and throughout the study period. | 
| Diet intake | Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays= | Every 8 week throughout the trial. | 
| Self-reported physical activity | International Physical Activity Questionnaire | 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 | Self-reported: Pittsburgh Sleep Quality Index | 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 | 
| Chronotype | Self-reported: Hornestberg Morningness Eveningness Questionnaire | 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 | Psychological general well being index (PGWBI) | 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 | Self-reported | From baseline to pregnancy (up to 36 weeks from enrollment) | 
| Psychological well-being | Self-reported: Psychological General Well Being Index | Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial. | 
| Birth weight (infant) | From hospital record | Delivery | 
| Birth length (infant) | From hospital record | Delivery | 
| Head circumference of infant | From hospital record | Delivery | 
| Apgar score | From hospital record | Delivery, after 1, 5 and 10 minutes | 
| ICU admission | From hospital record | Delivery | 
| Congenital malformation | From hospital record | Delivery | 
| Gestational age at birth | From hospital record | Delivery | 
| Length of stay at hospital | From hospital record | Delivery | 
| Blood pressure (Infant) | Blood pressure (systolic - and diastolic) | Within 72 hours of birth and after 6 weeks post delivery | 
| Cardiac function (Infant) | Ultrasound echocardiography Blood flow and myocardial function will be measured using mechanical wave imaging (MWI). | Within 72 hours of birth and after 6 weeks post delivery | 
| Infant total body mass | Estimated using impedance measurements (BioScan tough i8-nano) | Within 72 hours of birth and after 6 weeks post delivery | 
| Infant muscle mass | Estimated using impedance measurements (BioScan tough i8-nano) | Within 72 hours of birth and after 6 weeks post delivery | 
| Infant fat mass | Estimated using impedance measurements (BioScan tough i8-nano) | Within 72 hours of birth and after 6 weeks post delivery | 
| Infant hydration status | Estimated using impedance measurements (BioScan tough i8-nano) | Within 72 hours of birth and after 6 weeks post delivery | 
| Infant bone mass | Estimated using impedance measurements (BioScan tough i8-nano) | Within 72 hours of birth and after 6 weeks post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet therapy, Exercise therapy