Effect of Weight Loss and Lactation (the EVA-trial) (EVA)

Effect of Weight Loss and Lactation on Cardiovascular Risk Factors (the EVA-trial)

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Breastfeeding promotion intervention; Behavioral: Diet and weight loss intervention

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0317
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Breastfeeding promotion intervention (BPI)	Behavioral: Breastfeeding promotion intervention; Promotion (education, support and supervision) of breastfeeding by experienced breastfeeding consultants and midwife, in order to follow the Norwegian guideline of 6 months exclusive breastfeeding and partial breastfeeding for a year.
Experimental: Diet- and weight loss intervention (D)	Behavioral: Diet and weight loss intervention; 12-week program of dietary behavior modification treatment (LEVA-method by Bertz et al. Am J Clin Nutr 2012;96:698), leading to 6 kg weight loss (0.5 kg per week) and a healthier diet (less sugar, snacks, full fat products, more vegetables and fruit, smaller portion sizes). Weight is monitored by phone contact every second week. After 12 weeks, the women are followed up by e-mail contact for 9 additional months.
Experimental: BPI and D; Both interventions.	Behavioral: Breastfeeding promotion intervention; Promotion (education, support and supervision) of breastfeeding by experienced breastfeeding consultants and midwife, in order to follow the Norwegian guideline of 6 months exclusive breastfeeding and partial breastfeeding for a year.; Behavioral: Diet and weight loss intervention; 12-week program of dietary behavior modification treatment (LEVA-method by Bertz et al. Am J Clin Nutr 2012;96:698), leading to 6 kg weight loss (0.5 kg per week) and a healthier diet (less sugar, snacks, full fat products, more vegetables and fruit, smaller portion sizes). Weight is monitored by phone contact every second week. After 12 weeks, the women are followed up by e-mail contact for 9 additional months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight (kg) between visits.	Measured in light clothing without shoes. Together with measured height (m) will be used to calculate Body Mass Index.	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in markers of lipid- and glucose metabolism between visits.	Measured in mmol/l: total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides and glucose In percentage: HbA1c In pmol/l: insulin.	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits	In g/l: apolipoprotein (apo) B and apo A1. In mmol/l: lipoprotein (a)	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in blood pressure, diastolic and systolic between visits	Measured after 5 min rest, mean of last 2 of 3 measurements (mmHg)	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)
Changes in waist and hip (cm) circumference between visits	A measuring tape specifically designed for waist circumference (Seca) will be used according to a standardized procedure Measurements will be taken against the skin at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Hip is measured over the widest point on the buttocks.	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in body composition (fat free mass in kg and fat mass in kg) between visits.	Measured by Bioelectrical impedance and Dual X-ray Absorptiometry	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in circulating inflammation markers such as cytokines, high sensitivity C-Reactive Protein (hsCRP), CRP and microCRP between visits.	Measured in mg/l	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in environmental toxins in breast milk and blood, such as dioxines and Persistent Organic Pollutants (POPs) between visits.	Presented on lipid weight basis (ng/g)	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits.	Measured in mmol/l	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in PBMC (peripheral blood mononuclear cell) gene expression levels of markers of inflammation and lipid metabolism between visits.	Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level.	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in hemostatic markers such as plasminogen activator inhibitor-1 (PAI-1) antigen and von Willebrand factor (vWF) between visits.	PAI-1 measured in ng/mL, vWF measured in IU/dl	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in hormones such as prolactin, estradiol, progesterone between visits.	Measured in nmol/l	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in markers of micronutrient status such as Hb, ferritin and vitamin D between visits.	Ferritin will be evaluated in relation to CRP.	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in dietary intake (kcal) and nutrient composition measured by 4-day weighed diet record between 3 visits	Nutrient composition calculation in nutrient composition software Dietist Net Pro	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in physical activity (METs, activity counts, step counts) between visits.	measured by ActiGraph (GT3X)	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in quality of life (QOL) measured by RAND 36-Item Short-Form Health Survey Instrument (SF-36) between visits.	The SF-36 RAND consists of 36 questions grouped into 8 dimensions: physical functioning, limitations in physical role functioning, bodily pain, general health, vitality, social functioning, limitations in emotional role functioning, and mental health. Each dimension is scored from 0 (worst imaginable health) to 100 (best imaginable health).	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in quality of life (QOL) measured by EuroQol 5D (EQ-5D-5L) between visits.	EQ-5D-5L measures 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (self-classified). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions (levels of perceived problems from 1. level indicating no problem to 5. level indicating extreme problems). This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. EQ-5D-5L health states may be converted into a single index value.The index values, presented in country specific value sets, facilitates the calculation of quality-adjusted life years (QALYs) that will be used to inform economic evaluations of the interventions.	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Changes in quality of life (QOL) measured by EuroQol Visual Analog Scale (EQ-VAS) between visits.	The EQ-VAS records the respondent's self-rated health on a 20-cm visual analogue scale . The scale is numbered from 0 (the worst health you can imagine) to 100 (the best health you can imagine.) This information can be used as a quantitative measure of health.	Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Principal Investigator: Hilde K Brekke, PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2017/FO148194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No