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. 2023 Oct 4;13(10):e073572.
doi: 10.1136/bmjopen-2023-073572.

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

Md Abu Jafar Sujan  1   2 , Hanna Margrethe Storheil Skarstad  1 , Guro Rosvold  1 , Stine Lyngvi Fougner  3   4 , Siri Ann Nyrnes  1   5 , Ann-Charlotte Iversen  1   6 , Turid Follestad  4   7 , Kjell Å Salvesen  2   4 , Trine Moholdt  8   2
Affiliations

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

Md Abu Jafar Sujan et al. BMJ Open. .

Abstract

Introduction: Gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes in the mother and cardiometabolic diseases in the child. The preconception period is an optimal window to adapt the lifestyle for improved outcomes for both mother and child. Our aim is to determine the effect of a lifestyle intervention, initiated before and continued throughout pregnancy, on maternal glucose tolerance and other maternal and infant cardiometabolic outcomes.

Methods and analysis: This ongoing randomised controlled trial has included 167 females aged 18-39 years old at increased risk for GDM who are contemplating pregnancy. The participants were randomly allocated 1:1 to an intervention or control group. The intervention consists of exercise (volume is set by a heart rate-based app and corresponds to ≥ 1 hour of weekly exercise at ≥ 80% of individual heart rate maximum), and time-restricted eating (≤ 10 hours/day window of energy intake). The primary outcome measure is glucose tolerance in gestational week 28. Maternal and offspring outcomes are measured before and during pregnancy, at delivery, and at 6-8 weeks post partum. Primary and secondary continuous outcome measures will be compared between groups based on the 'intention to treat' principle using linear mixed models.

Ethics and dissemination: The Regional Committees for Medical and Health Research Ethics in Norway has approved the study (REK 143756). The anonymised results will be submitted for publication and posted in a publicly accessible database of clinical study results.

Trial registration number: Clinical trial gov NCT04585581.

Keywords: clinical trial; diabetes in pregnancy; fetal medicine; maternal medicine; nutrition & dietetics; obesity.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Consort flow diagram of the BEFORE THE BEGINNING trial (ongoing study: status 25 September 2020–17 July 2023). *If the participants are not pregnant within 12 months of inclusion, they are excluded from the study. From December 2022, the time window for exclusion if not pregnant was reduced from 12 to 6 months.
Figure 2
Figure 2
Overview of timepoints for assessments in the trial.
See this image and copyright information in PMC

References

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    1. Vinter CA, Tanvig MH, Christensen MH, et al. Lifestyle intervention in Danish obese pregnant women with early gestational diabetes mellitus according to WHO 2013 criteria does not change pregnancy outcomes: results from the lip (lifestyle in pregnancy) study. Diabetes Care 2018;41:2079–85. 10.2337/dc18-0808 - DOI - PubMed

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