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

NCT03580057 | Completed

• 1 other identifier: 2017/FO148194
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 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 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)

• 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)

Other Outcomes (12)

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

  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.

  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.

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

Study Arms (4)

Breastfeeding promotion intervention (BPI)

EXPERIMENTAL

Behavioral: Breastfeeding promotion intervention

Diet- and weight loss intervention (D)

EXPERIMENTAL

Behavioral: Diet and weight loss intervention

BPI and D

EXPERIMENTAL

Both interventions.

Behavioral: Breastfeeding promotion intervention; Behavioral: Diet and weight loss intervention

Control

NO INTERVENTION

Interventions

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.

BPI and D; Breastfeeding promotion intervention (BPI)

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.

BPI and D; Diet- and weight loss intervention (D)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, 0317, Norway

Location

Related Publications (1)

• Ohman EA, Fossli M, Rasmussen KM, Winkvist A, Loland BF, Holven KB, Brekke HK. Effects of Breastfeeding Promotion Intervention and Dietary Treatment in Postpartum Women with Overweight and Obesity: Results from a Randomized Controlled Trial on Weight and Cardiometabolic Risk Factors. J Nutr. 2024 Aug;154(8):2448-2458. doi: 10.1016/j.tjnut.2024.06.006. Epub 2024 Jun 18.

  PMID: 38901636 DERIVED

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hilde K Brekke, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: July 9, 2018
• Study Start: January 30, 2018
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

NO (1)