University of Oslo
Oslo, 0317, Norway
NCT Number: NCT03579667
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
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Notify Me18 year and older
Female
Interventional
Not applicable
Oslo, 0317, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured in light clothing without shoes. Together with measured height (m) will be used to calculate Body Mass Index.
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
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 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
In g/l: apolipoprotein (apo) B and apo A1. In mmol/l: lipoprotein (a)
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured after 5 min rest, mean of 2 measurements (mmHg)
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
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 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured by Bioelectrical impedance
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured in mg/l
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured in mmol/l
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Changes in levels of markers of inflammation and lipid metabolism at PBMC gene expression level.
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
PAI-1 measured in ng/mL, vWF measured in IU/dl
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured in nmol/l
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Measured in g/dl (Hb), nm/l (vit D)
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
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.
Time frame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
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.
University of Oslo
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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