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NCT Number: NCT04585581

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-restricted eating

Behavioral

Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.

High intensity exercise

Behavioral

Participants will be encouraged to exercise with high intensity 2-3 times per week

Standard care

Other

Standard clinical care

Primary outcomes

  1. Plasma glucose concentration

    Time frame: Gestational week 28

    Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)

Secondary outcomes

  1. Plasma glucose concentration

    Time frame: Gestational week 12

    Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)

  2. HbA1c

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Measured in the maternal blood

  3. Total cholesterol

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Measured in the maternal blood

  4. Triglycerides

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Measured in the maternal blood

  5. High density lipoprotein cholesterol

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Measured in the maternal blood

  6. Low density lipoprotein cholesterol

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Measured in the maternal blood

  7. Low density cholesterol

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Measured in the maternal blood

  8. Glucose

    Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)

    Measured in the blood

  9. Insulin

    Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)

    Measured in the blood

  10. Cytokines

    Time frame: 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)

  11. Adipokines (Adiponectin, Leptin, Ghrelin)

    Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)

    Measured in the maternal blood

  12. Homocysteine

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Measured in the maternal blood

  13. Insulin sensitivity

    Time frame: 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)

  14. Total body mass

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Estimated using InBody720 bioimpedance scale.

  15. Fat mass

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Estimated using InBody720 bioimpedance scale.

  16. Muscle mass

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Estimated using InBody720 bioimpedance scale.

  17. Visceral fat area

    Time frame: Baseline, intervention week 8, gestational week 12 and 28

    Estimated using InBody720 bioimpedance scale.

  18. Continuous glucose monitoring

    Time frame: Baseline and 8 weeks intervention

    Continuous glucose monitoring using Freestyle Libre (Abbott Diabetes Care), worn for 14 days.

  19. Cardiorespiratory fitness

    Time frame: Baseline and intervention week 8

    Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer.

  20. Blood pressure

    Time frame: 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).

  21. Measured physical activity

    Time frame: Baseline

    Measured by SenseWear activity monitor, worn for 7 days.

  22. Measured physical activity

    Time frame: From baseline and throughout the study period.

    Measured by Amazfit GTS smartwatch

  23. Diet intake

    Time frame: Every 8 week throughout the trial.

    Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays=

  24. Self-reported physical activity

    Time frame: 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

  25. Sleep

    Time frame: 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

  26. Chronotype

    Time frame: 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

  27. Psychological general well being

    Time frame: 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)

  28. Time to pregnancy

    Time frame: From baseline to pregnancy (up to 36 weeks from enrollment)

    Self-reported

  29. Psychological well-being

    Time frame: Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.

    Self-reported: Psychological General Well Being Index

  30. Birth weight (infant)

    Time frame: Delivery

    From hospital record

  31. Birth length (infant)

    Time frame: Delivery

    From hospital record

  32. Head circumference of infant

    Time frame: Delivery

    From hospital record

  33. Apgar score

    Time frame: Delivery, after 1, 5 and 10 minutes

    From hospital record

  34. ICU admission

    Time frame: Delivery

    From hospital record

  35. Congenital malformation

    Time frame: Delivery

    From hospital record

  36. Gestational age at birth

    Time frame: Delivery

    From hospital record

  37. Length of stay at hospital

    Time frame: Delivery

    From hospital record

  38. Blood pressure (Infant)

    Time frame: Within 72 hours of birth and after 6 weeks post delivery

    Blood pressure (systolic - and diastolic)

  39. Cardiac function (Infant)

    Time frame: 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).

  40. Infant total body mass

    Time frame: Within 72 hours of birth and after 6 weeks post delivery

    Estimated using impedance measurements (BioScan tough i8-nano)

  41. Infant muscle mass

    Time frame: Within 72 hours of birth and after 6 weeks post delivery

    Estimated using impedance measurements (BioScan tough i8-nano)

  42. Infant fat mass

    Time frame: Within 72 hours of birth and after 6 weeks post delivery

    Estimated using impedance measurements (BioScan tough i8-nano)

  43. Infant hydration status

    Time frame: Within 72 hours of birth and after 6 weeks post delivery

    Estimated using impedance measurements (BioScan tough i8-nano)

  44. Infant bone mass

    Time frame: Within 72 hours of birth and after 6 weeks post delivery

    Estimated using impedance measurements (BioScan tough i8-nano)

Other outcomes

  1. Infant gut microbiome

    Time frame: Within one week of birth, after 6 weeks and after 6 months

    Sequencing of faecal samples

  2. Maternal gut microbiome

    Time frame: After 6 weeks after delivery and after 6 months

    Sequencing of faecal samples

  3. Breastmilk composition

    Time frame: After 6 weeks after delivery and after 6 months

    Breastmilk sampling, for storage (outcomes will be exploratory, not yet specified)

  4. Infant total body mass

    Time frame: At age of 6 months

    Estimated using impedance measurements (BioScan tough i8-nano)

  5. Infant fat mass

    Time frame: At age of 6 months

    Estimated using impedance measurements (BioScan tough i8-nano)

  6. Infant muscle mass

    Time frame: At age of 6 months

    Estimated using impedance measurements (BioScan tough i8-nano)

  7. Infant hydration status

    Time frame: At age of 6 months

    Estimated using impedance measurements (BioScan tough i8-nano)

  8. Infant bone mass

    Time frame: At age of 6 months

    Estimated using impedance measurements (BioScan tough i8-nano)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Oct 14, 2020
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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