Clinical trial NCT03580057: Effect of Weight Loss and Lactation (the EVA-trial)
Official title: Effect of Weight Loss and Lactation on Cardiovascular Risk Factors (the EVA-trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: A randomized controlled trial aiming to investigate the effects and possible interactions of diet induced weight loss and lactation on cardiometabolic profile


Eligibility criteria: 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

Primary outcomes:
measure: Changes in body weight (kg) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in markers of lipid- and glucose metabolism between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Secondary outcomes:
measure: Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in blood pressure, diastolic and systolic between visits
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)
measure: Changes in waist and hip (cm) circumference between visits
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in body composition (fat free mass in kg and fat mass in kg) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Other outcomes:
measure: Changes in circulating inflammation markers such as cytokines, high sensitivity C-Reactive Protein (hsCRP), CRP and microCRP between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in environmental toxins in breast milk and blood, such as dioxines and Persistent Organic Pollutants (POPs) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in PBMC (peripheral blood mononuclear cell) gene expression levels of markers of inflammation and lipid metabolism between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in hemostatic markers such as plasminogen activator inhibitor-1 (PAI-1) antigen and von Willebrand factor (vWF) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in hormones such as prolactin, estradiol, progesterone between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in markers of micronutrient status such as Hb, ferritin and vitamin D between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in dietary intake (kcal) and nutrient composition measured by 4-day weighed diet record between 3 visits
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in physical activity (METs, activity counts, step counts) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in quality of life (QOL) measured by RAND 36-Item Short-Form Health Survey Instrument (SF-36) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in quality of life (QOL) measured by EuroQol 5D (EQ-5D-5L) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
measure: Changes in quality of life (QOL) measured by EuroQol Visual Analog Scale (EQ-VAS) between visits.
timeFrame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Hilde K Brekke, PhD
role: PRINCIPAL_INVESTIGATOR
References: