NCT03579667

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

4.1 years

First QC Date

June 25, 2018

Last Update Submit

October 26, 2021

Conditions

Cardiovascular Risk FactorBody Weight

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • 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)]

  • +7 more secondary outcomes

Study Arms (2)

Diet intervention

EXPERIMENTAL
Behavioral: Diet intervention

Control

NO INTERVENTION

Interventions

Diet interventionBEHAVIORAL

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.

Diet intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen With prepregnant overweight or obesity (BMI\>27)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women admitted to Adipol, Oslo University Hospital, Norway (outpatient clinic for women with overweight or obesity during pregnancy)

You may not qualify if:

  • Twin birth,
  • Non-Norwegian speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0317, Norway

Location

Related Publications (1)

  • 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.

    PMID: 37752466DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 6, 2018

Study Start

August 15, 2017

Primary Completion

September 29, 2021

Study Completion

September 29, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Locations

NO(1)