Clinical trial NCT03579667: Lipid Profile and Weight After Pregnancy
Official title: Lipid Profile and Weight After Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Body Weight
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Changes in body weight (kg) between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in markers of lipid- and glucose metabolism between visits
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Secondary outcomes:
measure: Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in blood pressure, diastolic and systolic between visits
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in waist and hip (cm) circumference between visits
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in body composition (fat free mass in kg and fat mass in kg) between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in circulating inflammation markers such as cytokines, high sensitivity C-Reactive Protein, C-Reactive Protein (CRP) and microCRP between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in PBMC (peripheral blood mononuclear cell) gene expression levels of markers of inflammation and lipid metabolism between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in hemostatic markers such as plasminogen activator inhibitor-1 (PAI-1) antigen and von Willebrand factor (vWF) between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in hormones such as prolactin, estradiol, progesterone between visits
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in markers of micronutrient status such as Hb and vitamin D between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in dietary intake and Food Choice by food frequency questionnaire at each of the 3 visits
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
measure: Changes in physical activity between visits.
timeFrame: Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References: