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Completed

NCT Number: NCT03580057

Effect of Weight Loss and Lactation (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

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Key information

Conditions

Cardiovascular Risk Factor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0317, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding promotion intervention

Behavioral

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.

Diet and weight loss intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    In g/l: apolipoprotein (apo) B and apo A1. In mmol/l: lipoprotein (a)

  2. Changes in blood pressure, diastolic and systolic between visits

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)

    Measured after 5 min rest, mean of last 2 of 3 measurements (mmHg)

  3. Changes in waist and hip (cm) circumference between visits

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    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.

  4. Changes in body composition (fat free mass in kg and fat mass in kg) between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    Measured by Bioelectrical impedance and Dual X-ray Absorptiometry

Other outcomes

  1. Changes in circulating inflammation markers such as cytokines, high sensitivity C-Reactive Protein (hsCRP), CRP and microCRP between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    Measured in mg/l

  2. Changes in environmental toxins in breast milk and blood, such as dioxines and Persistent Organic Pollutants (POPs) between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    Presented on lipid weight basis (ng/g)

  3. Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids 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

  4. Changes in PBMC (peripheral blood mononuclear cell) gene expression levels of markers of inflammation and lipid metabolism between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level.

  5. Changes in hemostatic markers such as plasminogen activator inhibitor-1 (PAI-1) antigen and von Willebrand factor (vWF) between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    PAI-1 measured in ng/mL, vWF measured in IU/dl

  6. Changes in hormones such as prolactin, estradiol, progesterone between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    Measured in nmol/l

  7. Changes in markers of micronutrient status such as Hb, ferritin and vitamin D between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    Ferritin will be evaluated in relation to CRP.

  8. Changes in dietary intake (kcal) and nutrient composition measured by 4-day weighed diet record between 3 visits

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    Nutrient composition calculation in nutrient composition software Dietist Net Pro

  9. Changes in physical activity (METs, activity counts, step counts) between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    measured by ActiGraph (GT3X)

  10. Changes in quality of life (QOL) measured by RAND 36-Item Short-Form Health Survey Instrument (SF-36) between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    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).

  11. Changes in quality of life (QOL) measured by EuroQol 5D (EQ-5D-5L) between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    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.

  12. Changes in quality of life (QOL) measured by EuroQol Visual Analog Scale (EQ-VAS) between visits.

    Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)

    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.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Acronym: EVA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2018
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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