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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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diet + training

Group Type EXPERIMENTAL

time-restricted eating

Intervention Type BEHAVIORAL

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

high intensity exercise

Intervention Type BEHAVIORAL

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

Standard Care

Intervention Type OTHER

Standard clinical care

controls

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

Standard clinical care

Interventions

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time-restricted eating

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

Intervention Type BEHAVIORAL

high intensity exercise

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

Intervention Type BEHAVIORAL

Standard Care

Standard clinical care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No