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

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

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

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Breastfeeding promotion intervention
* Behavioral: Diet and weight loss intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding promotion intervention (BPI)<br> | Behavioral: Breastfeeding promotion intervention<br>* 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.<br>|
| Experimental: Diet- and weight loss intervention (D)<br> | Behavioral: Diet and weight loss intervention<br>* 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.<br>|
| Experimental: BPI and D<br>Both interventions. | Behavioral: Breastfeeding promotion intervention<br>* 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.<br>Behavioral: Diet and weight loss intervention<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits | In g/l: apolipoprotein (apo) B and apo A1. In mmol/l: lipoprotein (a) | 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 | Measured after 5 min rest, mean of last 2 of 3 measurements (mmHg) | 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 | 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. | 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. | Measured by Bioelectrical impedance and Dual X-ray Absorptiometry | Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning  15 months postpartum) |