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

Norwegian University of Science and Technology

Status: Active, not recruiting

Conditions: Gestational Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04585581

143756

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

diet + training

Experimental group

Treatment:

Other: Standard Care

Behavioral: time-restricted eating

Behavioral: high intensity exercise

controls

Active Comparator group

Treatment:

Other: Standard Care