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

University of Oslo

Status: Completed

Conditions: Cardiovascular Risk Factor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03580057

2017/FO148194

Details and patient eligibility

About

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

Enrollment: 156 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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156 participants in 4 patient groups

Breastfeeding promotion intervention (BPI)

Experimental group

Treatment:

Behavioral: Breastfeeding promotion intervention

Diet- and weight loss intervention (D)

Experimental group

Treatment:

Behavioral: Diet and weight loss intervention

BPI and D

Experimental group

Description:

Both interventions.

Treatment:

Behavioral: Diet and weight loss intervention

Behavioral: Breastfeeding promotion intervention

Control

No Intervention group