Gestational DiabetesNCT04585581
Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)
A study testing time-restricted eating and high intensity exercise in people with Gestational Diabetes, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- time-restricted eating and high intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteNorway
- Study dates
- 6 Nov 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health
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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- time-restricted eating, high intensity exercise, Standard Care
- Keywords
- Diet therapy, Exercise therapy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time-restricted eatingBehavioural
Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.
high intensity exerciseBehavioural
Participants will be encouraged to exercise with high intensity 2-3 times per week
Standard CareOther
Standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| diet + training | Experimental | Not described Receives: Behavioral: time-restricted eating; Behavioral: high intensity exercise; Other: Standard Care |
| controls | Active comparator | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose concentration
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Measured: Gestational week 28
Secondary outcomes (44)
Plasma glucose concentration
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
Measured: Gestational week 12
HbA1c
Measured in the maternal blood
Measured: Baseline, intervention week 8, gestational week 12 and 28
Total cholesterol
Measured in the maternal blood
Measured: Baseline, intervention week 8, gestational week 12 and 28
Triglycerides
Measured in the maternal blood
Measured: Baseline, intervention week 8, gestational week 12 and 28
High density lipoprotein cholesterol
Measured in the maternal blood
Measured: Baseline, intervention week 8, gestational week 12 and 28
Low density lipoprotein cholesterol
Measured in the maternal blood
Measured: Baseline, intervention week 8, gestational week 12 and 28
Low density cholesterol
Measured in the maternal blood
Measured: Baseline, intervention week 8, gestational week 12 and 28
Glucose
Measured in the blood
Measured: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Insulin
Measured in the blood
Measured: 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)
Measured: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Adipokines (Adiponectin, Leptin, Ghrelin)
Measured in the maternal blood
Measured: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Homocysteine
Measured in the maternal blood
Measured: 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)
Measured: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Total body mass
Estimated using InBody720 bioimpedance scale.
Measured: Baseline, intervention week 8, gestational week 12 and 28
Fat mass
Estimated using InBody720 bioimpedance scale.
Measured: Baseline, intervention week 8, gestational week 12 and 28
Muscle mass
Estimated using InBody720 bioimpedance scale.
Measured: Baseline, intervention week 8, gestational week 12 and 28
Visceral fat area
Estimated using InBody720 bioimpedance scale.
Measured: 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.
Measured: Baseline and 8 weeks intervention
Cardiorespiratory fitness
Peak oxygen uptake at a maximum effort exercise test, measured in L/min using Metalyzer.
Measured: 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).
Measured: Baseline, intervention week 8, gestational week 12 and 28
Measured physical activity
Measured by SenseWear activity monitor, worn for 7 days.
Measured: Baseline
Measured physical activity
Measured by Amazfit GTS smartwatch
Measured: From baseline and throughout the study period.
Diet intake
Online food diary (Lifesum app), 4-day registration (one weekend day and three weekdays=
Measured: Every 8 week throughout the trial.
Self-reported physical activity
International Physical Activity Questionnaire
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: From baseline to pregnancy (up to 36 weeks from enrollment)
Psychological well-being
Self-reported: Psychological General Well Being Index
Measured: Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.
Birth weight (infant)
From hospital record
Measured: Delivery
Birth length (infant)
From hospital record
Measured: Delivery
Head circumference of infant
From hospital record
Measured: Delivery
Apgar score
From hospital record
Measured: Delivery, after 1, 5 and 10 minutes
ICU admission
From hospital record
Measured: Delivery
Congenital malformation
From hospital record
Measured: Delivery
Gestational age at birth
From hospital record
Measured: Delivery
Length of stay at hospital
From hospital record
Measured: Delivery
Blood pressure (Infant)
Blood pressure (systolic - and diastolic)
Measured: 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).
Measured: Within 72 hours of birth and after 6 weeks post delivery
Infant total body mass
Estimated using impedance measurements (BioScan tough i8-nano)
Measured: Within 72 hours of birth and after 6 weeks post delivery
Infant muscle mass
Estimated using impedance measurements (BioScan tough i8-nano)
Measured: Within 72 hours of birth and after 6 weeks post delivery
Infant fat mass
Estimated using impedance measurements (BioScan tough i8-nano)
Measured: Within 72 hours of birth and after 6 weeks post delivery
Infant hydration status
Estimated using impedance measurements (BioScan tough i8-nano)
Measured: Within 72 hours of birth and after 6 weeks post delivery
Infant bone mass
Estimated using impedance measurements (BioScan tough i8-nano)
Measured: Within 72 hours of birth and after 6 weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start6 Nov 2020
- Primary completion5 Feb 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, Study director, Norwegian University of Science and Technology, Fac MH ISBKjell Å Salvesen, md prof, Study director, St Olavs Hospital, Dept Obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585581
- Sponsor's protocol ID
- 143756
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share individual participant data that underlie the results in publications, after deidentification (text, tables, figures, and appendices).
Publications
Sujan MJ, Skarstad HM, Rosvold G, Fougner SL, Follestad T, Salvesen KA, Moholdt T. Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING). BMJ. 2025 Sep 9;390:e083398. doi: 10.1136/bmj-2024-083398.
PubMed 40925657Sujan MAJ, Skarstad HMS, Rosvold G, Fougner SL, Nyrnes SA, Iversen AC, Follestad T, Salvesen KA, Moholdt T. Randomised controlled trial of preconception lifestyle intervention on maternal and offspring health in people with increased risk of gestational diabetes: study protocol for the BEFORE THE BEGINNING trial. BMJ Open. 2023 Oct 4;13(10):e073572. doi: 10.1136/bmjopen-2023-073572.
PubMed 37793933
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health
- ClinicalTrials.gov ID
- NCT04585581
- Acronym / sponsor ID
- 143756
- Conditions
- Gestational Diabetes
- Keywords
- Diet therapy, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet + training | Experimental | Behavioral: time-restricted eating, Behavioral: high intensity exercise, Other: Standard Care |
| controls | Active comparator | Other: Standard Care |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| time-restricted eatingParticipants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours. | Behavioural | diet + training |
| high intensity exerciseParticipants will be encouraged to exercise with high intensity 2-3 times per week | Behavioural | diet + training |
| Standard CareStandard clinical care | Other | controls, diet + training |
Primary outcome
Plasma glucose concentration
Time frame: Gestational week 28
Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)
44 secondary outcomes
Plasma glucose concentration
Time frame: Gestational week 12
HbA1c
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Total cholesterol
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Triglycerides
Time frame: Baseline, intervention week 8, gestational week 12 and 28
High density lipoprotein cholesterol
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Low density lipoprotein cholesterol
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Low density cholesterol
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Glucose
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Insulin
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Cytokines
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Adipokines (Adiponectin, Leptin, Ghrelin)
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Homocysteine
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Insulin sensitivity
Time frame: Baseline, intervention week 8, gestational week 12 and 28, and in cord blood (delivery)
Total body mass
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Fat mass
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Muscle mass
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Visceral fat area
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Continuous glucose monitoring
Time frame: Baseline and 8 weeks intervention
Cardiorespiratory fitness
Time frame: Baseline and intervention week 8
Blood pressure
Time frame: Baseline, intervention week 8, gestational week 12 and 28
Measured physical activity
Time frame: Baseline
Measured physical activity
Time frame: From baseline and throughout the study period.
Diet intake
Time frame: Every 8 week throughout the trial.
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
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
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
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
Time to pregnancy
Time frame: From baseline to pregnancy (up to 36 weeks from enrollment)
Psychological well-being
Time frame: Baseline, intervention week 8, gestational week 12 and 28 and every 8 week throughout the trial.
Birth weight (infant)
Time frame: Delivery
Birth length (infant)
Time frame: Delivery
Head circumference of infant
Time frame: Delivery
Apgar score
Time frame: Delivery, after 1, 5 and 10 minutes
ICU admission
Time frame: Delivery
Congenital malformation
Time frame: Delivery
Gestational age at birth
Time frame: Delivery
Length of stay at hospital
Time frame: Delivery
Blood pressure (Infant)
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Cardiac function (Infant)
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Infant total body mass
Time frame: Within 72 hours of birth and after 6 weeks post delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 40925657Sujan MJ, Skarstad HM, Rosvold G, Fougner SL, Follestad T, Salvesen KA, Moholdt T. Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING). BMJ. 2025 Sep 9;390:e083398. doi: 10.1136/bmj-2024-083398.
- Derived from this study: PubMed 37793933Sujan MAJ, Skarstad HMS, Rosvold G, Fougner SL, Nyrnes SA, Iversen AC, Follestad T, Salvesen KA, Moholdt T. Randomised controlled trial of preconception lifestyle intervention on maternal and offspring health in people with increased risk of gestational diabetes: study protocol for the BEFORE THE BEGINNING trial. BMJ Open. 2023 Oct 4;13(10):e073572. doi: 10.1136/bmjopen-2023-073572.
- Individual participant dataSharing planned: Yes. We will share individual participant data that underlie the results in publications, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa study director
Norwegian University of Science and Technology, Fac MH ISB
Kjell Å Salvesen, md prof study director
St Olavs Hospital, Dept Obstetrics & Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time-restricted eating and high intensity exercise in people with Gestational Diabetes, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose concentration (time frame: Gestational week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.