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

NCT03580057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-03-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Oslo

    lead OTHER

Principal Investigators

  • Hilde K Brekke, PhD · University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03580057 on ClinicalTrials.gov