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

Browse trials for

• Weight Loss 1,766

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 156 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Lead sponsor

University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.

Study arms

• Experimental
  Breastfeeding promotion intervention (BPI)

  Behavioral: Breastfeeding promotion intervention

• Experimental
  Diet- and weight loss intervention (D)

  Behavioral: Diet and weight loss intervention

• Experimental
  BPI and D

  Both interventions.

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

• No intervention
  Control

Interventions

• BehavioralBreastfeeding 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.

• BehavioralDiet 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.

Primary outcomes

1. 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.

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

2. 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.

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

Secondary outcomes

1. 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)

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

2. Changes in blood pressure, diastolic and systolic between visits

   Measured after 5 min rest, mean of last 2 of 3 measurements (mmHg)

   Time frame: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)

3. 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.

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

4. 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

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

Other outcomes

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

   Measured in mg/l

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

2. Changes in environmental toxins in breast milk and blood, such as dioxines and Persistent Organic Pollutants (POPs) between visits.

   Presented on lipid weight basis (ng/g)

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

3. Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits.

   Measured in mmol/l

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

4. Changes in PBMC (peripheral blood mononuclear cell) gene expression levels of markers of inflammation and lipid metabolism between visits.

   Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level.

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

5. Changes in hemostatic markers such as plasminogen activator inhibitor-1 (PAI-1) antigen and von Willebrand factor (vWF) between visits.

   PAI-1 measured in ng/mL, vWF measured in IU/dl

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

6. Changes in hormones such as prolactin, estradiol, progesterone between visits.

   Measured in nmol/l

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

7. Changes in markers of micronutrient status such as Hb, ferritin and vitamin D between visits.

   Ferritin will be evaluated in relation to CRP.

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

8. Changes in dietary intake (kcal) and nutrient composition measured by 4-day weighed diet record between 3 visits

   Nutrient composition calculation in nutrient composition software Dietist Net Pro

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

9. Changes in physical activity (METs, activity counts, step counts) between visits.

   measured by ActiGraph (GT3X)

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

10. Changes in quality of life (QOL) measured by RAND 36-Item Short-Form Health Survey Instrument (SF-36) between visits.

    The SF-36 RAND consists of 36 questions grouped into 8 dimensions: physical functioning, limitations in physical role functioning, bodily pain, general health, vitality, social functioning, limitations in emotional role functioning, and mental health. Each dimension is scored from 0 (worst imaginable health) to 100 (best imaginable health).

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

11. Changes in quality of life (QOL) measured by EuroQol 5D (EQ-5D-5L) between visits.

    EQ-5D-5L measures 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (self-classified). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions (levels of perceived problems from 1. level indicating no problem to 5. level indicating extreme problems). This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. EQ-5D-5L health states may be converted into a single index value.The index values, presented in country specific value sets, facilitates the calculation of quality-adjusted life years (QALYs) that will be used to inform economic evaluations of the interventions.

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

12. Changes in quality of life (QOL) measured by EuroQol Visual Analog Scale (EQ-VAS) between visits.

    The EQ-VAS records the respondent's self-rated health on a 20-cm visual analogue scale . The scale is numbered from 0 (the worst health you can imagine) to 100 (the best health you can imagine.) This information can be used as a quantitative measure of health.

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

Individual participant data

Plan to share: Undecided