NCT01918319

Brief Summary

Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

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

February 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

August 2, 2013

Last Update Submit

August 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index standard deviation score

    On average 2.9 years of age

Secondary Outcomes (1)

  • Fat mass percent

    On average 2.9 years of age

Other Outcomes (1)

  • Anthropometric and metabolic risk factors and bone mineralization

    On average 2.9 years of age

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation.

Behavioral: Lifestyle intervention

Control

NO INTERVENTION

Interventions

Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.

Lifestyle intervention

Eligibility Criteria

Age30 Months - 40 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • singleton pregnant
  • BMI \>/= 30 and \</= 45 E xclusion Criteria for preceding LiP study:
  • Chronic diseases
  • Not Danish speaking
  • Abuse of alcohol or drugs
  • Preterm delivery in earlier pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (4)

  • Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Jorgensen JS. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women. Diabetes Care. 2011 Dec;34(12):2502-7. doi: 10.2337/dc11-1150. Epub 2011 Oct 4.

    PMID: 21972411BACKGROUND
  • Luef BM, Stentebjerg LL, Tanvig MH, Aalders J, Moller S, Ovesen PG, Christesen HT, McIntyre HD, Catalano PM, Jorgensen JS, Overgaard M, Jensen DM, Vinter CA. Impact of maternal fasting blood glucose in pregnancy on body composition, anthropometric, and metabolic outcomes in newborns and 3-Year-Old offspring: results from the lifestyle in pregnancy and offspring study. BMC Pregnancy Childbirth. 2026 Jan 29. doi: 10.1186/s12884-026-08692-3. Online ahead of print.

  • Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Beck-Nielsen H, Christesen HT, Jensen DM. Effects of lifestyle intervention in pregnancy and anthropometrics at birth on offspring metabolic profile at 2.8 years: results from the Lifestyle in Pregnancy and Offspring (LiPO) study. J Clin Endocrinol Metab. 2015 Jan;100(1):175-83. doi: 10.1210/jc.2014-2675.

  • Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Lamont RF, Beck-Nielsen H, Christesen HT, Jensen DM. Anthropometrics and body composition by dual energy X-ray in children of obese women: a follow-up of a randomized controlled trial (the Lifestyle in Pregnancy and Offspring [LiPO] study). PLoS One. 2014 Feb 24;9(2):e89590. doi: 10.1371/journal.pone.0089590. eCollection 2014.

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mette Tanvig, MD

    Department of endocrinology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 7, 2013

Study Start

February 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations