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

NCT04585581 | Active Not Recruiting

• 1 other identifier: 143756
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes

Keywords

Diet therapy; Exercise therapy

Outcome Measures

Primary Outcomes (1)

• Plasma glucose concentration

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

  Gestational week 28

Secondary Outcomes (44)

• Plasma glucose concentration

  Gestational week 12

• HbA1c

  Baseline, intervention week 8, gestational week 12 and 28

• Total cholesterol

  Baseline, intervention week 8, gestational week 12 and 28

• Triglycerides

  Baseline, intervention week 8, gestational week 12 and 28

• High density lipoprotein cholesterol

  Baseline, intervention week 8, gestational week 12 and 28

Other Outcomes (8)

• Infant gut microbiome

  Within one week of birth, after 6 weeks and after 6 months

• Maternal gut microbiome

  After 6 weeks after delivery and after 6 months

• Breastmilk composition

  After 6 weeks after delivery and after 6 months

Study Arms (2)

diet + training

EXPERIMENTAL

Behavioral: time-restricted eating; Behavioral: high intensity exercise; Other: Standard Care

controls

ACTIVE COMPARATOR

Other: Standard Care

Interventions

time-restricted eating BEHAVIORAL

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

diet + training

high intensity exercise BEHAVIORAL

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

diet + training

Standard Care OTHER

Standard clinical care

controls; diet + training

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: collaborator
• Norwegian University of Science and Technology: lead

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• 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.

  PMID: 40925657 DERIVED

• 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.

  PMID: 37793933 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

High-Intensity Interval Training; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Øystein Risa

  Norwegian University of Science and Technology, Fac MH ISB

  STUDY DIRECTOR

• Kjell Å Salvesen, md prof

  St Olavs Hospital, Dept Obstetrics & Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 14, 2020
• Study Start: November 6, 2020
• Primary Completion: February 5, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication, with no end date.
• 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.

Locations

NO (1)