Lipid Profile and Weight After Pregnancy

Study Overview
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Brief Summary
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A randomized controlled trial aiming to investigate the effects of diet behavior intervention postpartum on body weight and lipid and metabolite profile in overweight and obese women in Oslo, Norway

Official Title
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Lipid Profile and Weight After Pregnancy

Conditions
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Cardiovascular Risk Factor, Body Weight

Intervention / Treatment
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* Behavioral: Diet intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women admitted to Adipol, Oslo University Hospital, Norway (outpatient clinic for women with overweight or obesity during pregnancy) Exclusion Criteria: Twin birth, Non-Norwegian speaking

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet intervention<br> | Behavioral: Diet 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 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (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 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (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 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in blood pressure, diastolic and systolic between visits | Measured after 5 min rest, mean of 2 measurements (mmHg) | Visit 1 (8 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 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in body composition (fat free mass in kg and fat mass in kg) between visits. | Measured by Bioelectrical impedance | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in circulating inflammation markers such as cytokines, high sensitivity C-Reactive Protein, C-Reactive Protein (CRP) and microCRP between visits. | Measured in mg/l | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits. | Measured in mmol/l | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| 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. | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| 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 | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in hormones such as prolactin, estradiol, progesterone between visits | Measured in nmol/l | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in markers of micronutrient status such as Hb and vitamin D between visits. | Measured in g/dl (Hb), nm/l (vit D) | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in dietary intake and Food Choice by food frequency questionnaire at each of the 3 visits | Energy (KJ/kcal), macronutrients and micronutrients will be calculated in Norwegian Food database program. The diet questionnaire is optically readable and has 11-pages. It contains 180 food items grouped by food groups; breads, spreads, cereals, milk, yoghurt, drinks (cold, warm, alcoholic), dinner foods (potatoes, rice, pasta, vegetables), sauces and dressings, fats, fruits, desserts/cakes/sweets/snacks, diet supplements. Frequencies are most often given in 9 categories, varying from rarely/never to 4 or more times per day, depending on food category. Portion-sizes are given as typical household units: slices, glasses, cups, pieces, spoons and ladle. | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] | 
| Changes in physical activity between visits. | Questions are asked about physical activity before and during pregnancy as well as current postpartum visit. At these timepoints, four dimensions of activities are examined; 1) everyday activities (four response categories from inactive (0 points) to heavy physical work (3 points)), 2) transportation (two response categories: passive (car/public transport, 0p), active (walk or bike 1p)), 3) leisure time/outdoor activity (five response categories from rarely (0p) to 4 times/week or more (4p)) and 4) 30 min continuous physical activity with increased pulse/being short-winded (five response categories from rarely (0p) to 4 times/week or more (4p)). Participants receive a score for each of the four dimensions. | Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)] |