An interventional study of time-restricted eating and high intensity exercise in Gestational Diabetes, sponsored by Norwegian University of Science and Technology. Active, not recruiting at 1 site in Norway. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Prevention
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 167 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: time-restricted eating · Behavioral: high intensity exercise · Other: Standard Care
Other: Standard Care
Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.
Participants will be encouraged to exercise with high intensity 2-3 times per week
Standard clinical care
Plasma glucose concentration
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Time frame: Gestational week 28
Plasma glucose concentration
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Time frame: Gestational week 12
HbA1c
Measured in the maternal blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Total cholesterol
Measured in the maternal blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Triglycerides
Measured in the maternal blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28
High density lipoprotein cholesterol
Measured in the maternal blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Low density lipoprotein cholesterol
Measured in the maternal blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Low density cholesterol
Measured in the maternal blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Glucose
Measured in the blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Insulin
Measured in the blood
Time frame: 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)
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Adipokines (Adiponectin, Leptin, Ghrelin)
Measured in the maternal blood
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Homocysteine
Measured in the maternal blood
Time frame: 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)
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Total body mass
Estimated using InBody720 bioimpedance scale.
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Fat mass
Estimated using InBody720 bioimpedance scale.
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Muscle mass
Estimated using InBody720 bioimpedance scale.
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Visceral fat area
Estimated using InBody720 bioimpedance scale.
Time frame: 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.
Time frame: Baseline and 8 weeks intervention
Cardiorespiratory fitness
Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer.
Time frame: 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).
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Measured physical activity
Measured by SenseWear activity monitor, worn for 7 days.
Time frame: Baseline
Measured physical activity
Measured by Amazfit GTS smartwatch
Time frame: From baseline and throughout the study period.
Diet intake
Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays=
Time frame: Every 8 week throughout the trial.
Self-reported physical activity
International Physical Activity Questionnaire
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
Sleep
Self-reported: Pittsburgh Sleep Quality Index
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
Chronotype
Self-reported: Hornestberg Morningness Eveningness Questionnaire
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
Psychological general well being index (PGWBI)
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
Time to pregnancy
Self-reported
Time frame: From baseline to pregnancy (up to 36 weeks from enrollment)
Psychological well-being
Self-reported: Psychological General Well Being Index
Time frame: Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.
Birth weight (infant)
From hospital record
Time frame: Delivery
Birth length (infant)
From hospital record
Time frame: Delivery
Head circumference of infant
From hospital record
Time frame: Delivery
Apgar score
From hospital record
Time frame: Delivery, after 1, 5 and 10 minutes
ICU admission
From hospital record
Time frame: Delivery
Congenital malformation
From hospital record
Time frame: Delivery
Gestational age at birth
From hospital record
Time frame: Delivery
Length of stay at hospital
From hospital record
Time frame: Delivery
Blood pressure (Infant)
Blood pressure (systolic - and diastolic)
Time frame: 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).
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Infant total body mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Infant muscle mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Infant fat mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Infant hydration status
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Infant bone mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Infant gut microbiome
Sequencing of faecal samples
Time frame: Within one week of birth, after 6 weeks and after 6 months
Maternal gut microbiome
Sequencing of faecal samples
Time frame: After 6 weeks after delivery and after 6 months
Breastmilk composition
Breastmilk sampling, for storage (outcomes will be exploratory, not yet specified)
Time frame: After 6 weeks after delivery and after 6 months
Infant total body mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: At age of 6 months
Infant fat mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: At age of 6 months
Infant muscle mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: At age of 6 months
Infant hydration status
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: At age of 6 months
Infant bone mass
Estimated using impedance measurements (BioScan tough i8-nano)
Time frame: At age of 6 months
Plan to share: Yes — We will share individual participant data that underlie the results in publications, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology