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Lipid Profile and Weight After Pregnancy

Primary Purpose

Cardiovascular Risk Factor, Body Weight

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Diet intervention
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Risk Factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diet intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
Changes in blood pressure, diastolic and systolic between visits
Measured after 5 min rest, mean of 2 measurements (mmHg)
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
Changes in body composition (fat free mass in kg and fat mass in kg) between visits.
Measured by Bioelectrical impedance
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
Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits.
Measured in mmol/l
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.
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
Changes in hormones such as prolactin, estradiol, progesterone between visits
Measured in nmol/l
Changes in markers of micronutrient status such as Hb and vitamin D between visits.
Measured in g/dl (Hb), nm/l (vit D)
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.
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.

Full Information

First Posted
June 25, 2018
Last Updated
October 26, 2021
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03579667
Brief Title
Lipid Profile and Weight After Pregnancy
Official Title
Lipid Profile and Weight After Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Body Weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Diet intervention
Intervention Description
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 Outcome Measure Information:
Title
Changes in body weight (kg) between visits.
Description
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)]
Title
Changes in markers of lipid- and glucose metabolism between visits
Description
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)]
Secondary Outcome Measure Information:
Title
Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits
Description
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)]
Title
Changes in blood pressure, diastolic and systolic between visits
Description
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)]
Title
Changes in waist and hip (cm) circumference between visits
Description
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)]
Title
Changes in body composition (fat free mass in kg and fat mass in kg) between visits.
Description
Measured by Bioelectrical impedance
Time Frame
Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Title
Changes in circulating inflammation markers such as cytokines, high sensitivity C-Reactive Protein, C-Reactive Protein (CRP) and microCRP between visits.
Description
Measured in mg/l
Time Frame
Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Title
Changes in plasma metabolomics such as lactate, pyruvate, citrate and amino acids between visits.
Description
Measured in mmol/l
Time Frame
Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Title
Changes in PBMC (peripheral blood mononuclear cell) gene expression levels of markers of inflammation and lipid metabolism between visits.
Description
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)]
Title
Changes in hemostatic markers such as plasminogen activator inhibitor-1 (PAI-1) antigen and von Willebrand factor (vWF) between visits.
Description
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)]
Title
Changes in hormones such as prolactin, estradiol, progesterone between visits
Description
Measured in nmol/l
Time Frame
Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]
Title
Changes in markers of micronutrient status such as Hb and vitamin D between visits.
Description
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)]
Title
Changes in dietary intake and Food Choice by food frequency questionnaire at each of the 3 visits
Description
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)]
Title
Changes in physical activity between visits.
Description
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.
Time Frame
Visit 1 (8 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum)]

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women With prepregnant overweight or obesity (BMI>27)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Oslo
City
Oslo
ZIP/Postal Code
0317
Country
Norway

12. IPD Sharing Statement

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Lipid Profile and Weight After Pregnancy

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