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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Behavioral: time-restricted eating; Behavioral: high intensity exercise; Other: Standard Care

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 Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant gut microbiome	Sequencing of faecal samples	Within one week of birth, after 6 weeks and after 6 months
Maternal gut microbiome	Sequencing of faecal samples	After 6 weeks after delivery and after 6 months
Breastmilk composition	Breastmilk sampling, for storage (outcomes will be exploratory, not yet specified)	After 6 weeks after delivery and after 6 months
Infant total body mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Infant fat mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Infant muscle mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Infant hydration status	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months
Infant bone mass	Estimated using impedance measurements (BioScan tough i8-nano)	At age of 6 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Director: Øystein Risa, Norwegian University of Science and Technology, Fac MH ISB; Study Director: Kjell Å Salvesen, md prof, St Olavs Hospital, Dept Obstetrics & Gynecology

Publications and helpful links

General 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.
• Sujan 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): February 5, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise therapy; Diet therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality of Health Care; Quality Indicators, Health Care; Physical Conditioning, Human; Exercise; Standard of Care; High-Intensity Interval Training
• Other Study ID Numbers: 143756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share individual participant data that underlie the results in publications, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication, with no end date.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposals, or for individual participant data meta-analyses. Proposals should be directed to trine.moholdt@ntnu.no. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No