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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Behavioral: Breastfeeding promotion intervention; Behavioral: Diet and weight loss intervention

• Registration Number: NCT03580057
• Lead Sponsor: University of Oslo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-09
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
BPI and D	Breastfeeding promotion intervention	Both interventions.
Breastfeeding promotion intervention (BPI)	Breastfeeding promotion intervention	-
Diet- and weight loss intervention (D)	Diet and weight loss intervention	-
BPI and D	Diet and weight loss intervention	Both interventions.

Primary Outcome Measures

Name	Time	Method
Changes in body weight (kg) between visits.	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.	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 Outcome Measures

Name	Time	Method
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)	Measured after 5 min rest, mean of last 2 of 3 measurements (mmHg)
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)	Measured by Bioelectrical impedance and Dual X-ray Absorptiometry
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)	In g/l: apolipoprotein (apo) B and apo A1. In mmol/l: lipoprotein (a)
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)	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.

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway