Effect of Weight Loss and Lactation on Cardiovascular Risk Factors (the EVA-trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oslo
- Enrollment
- 156
- Locations
- 2
- Primary Endpoint
- Changes in body weight (kg) between visits.
Study Overview
Brief Summary
A randomized controlled trial aiming to investigate the effects and possible interactions of diet induced weight loss and lactation on cardiometabolic profile
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women in gestational week <32, with a pre-pregnant BMI 25-35 kg/m2
- •Residence in Oslo/Bærum and surrounding area
- •Intention to breastfeed their child
- •Able to read and write in Norwegian.
Exclusion Criteria
- •Medication that influences lipid or glucose metabolism
- •Chronic disease that influences lipid or glucose metabolism (e.g. diabetes (World Health Organization, WHO, 2006) or diabetes in pregnancy (WHO 2013))
- •Premature birth (before week 36)
- •Preeclampsia
- •Previous breast reducing surgery
Outcomes
Primary Outcomes
Changes in body weight (kg) between visits.
Time Frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Measured in light clothing without shoes. Together with measured height (m) will be used to calculate Body Mass Index.
Changes in markers of lipid- and glucose metabolism between visits.
Time Frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Measured in mmol/l: total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides and glucose In percentage: HbA1c In pmol/l: insulin.
Secondary Outcomes
- Changes in blood pressure, diastolic and systolic between visits(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum))
- Changes in body composition (fat free mass in kg and fat mass in kg) between visits.(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum))
- Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum))
- Changes in waist and hip (cm) circumference between visits(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum))
Investigators
Hilde Kristin Brekke
Professor
University of Oslo