NCT03579667|Completed
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Sponsor study identifier
interventional
30
1 country
1
Study Start
August 15, 2017
Actual (reported)Primary Completion
September 29, 2021
Actual (reported)Study Completion
September 29, 2021
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 15, 2017
Actual (reported)June 25, 2018
Actual (reported)July 6, 2018
Actual (reported)September 29, 2021
Actual (reported)September 29, 2021
Actual (reported)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)]
Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits
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
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
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.
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.
Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Oslo
Oslo, 0317, Norway
Ohman EA, Fossli M, Ottestad I, Holven KB, Ulven SM, Loland BF, Brekke HK. Dietary treatment postpartum in women with obesity reduces weight and prevents weight gain: a randomised controlled trial. BMC Pregnancy Childbirth. 2023 Sep 26;23(1):695. doi: 10.1186/s12884-023-05976-w.
30 participants (actual enrollment reported by the registry).
First Submitted
June 25, 2018
First Posted
July 6, 2018
Study Start
August 15, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 29, 2021
Actual (reported)Study Completion
September 29, 2021
Actual (reported)Last Updated
October 27, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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