NCT05774652

Brief Summary

The study is a follow-up of a Randomized Controlled Trial (RCT) performed in 2007-10 - the "Lifestyle in Pregnancy" LiP study. The LiP study included 360 pregnant women with BMI ≥30 kg/m2 from Odense University Hospital and Aarhus University Hospital. The women were randomized to intervention with low-calorie diet and physical activity from gestational age 10-14 in pregnancy and until delivery - or to a standard care control group. The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring. The overall ambition is to understand whether lifestyle intervention in pregnancy prevents obesity and its complications across generations, with a specific focus on modifiable factors.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
301

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 19, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

February 16, 2023

Last Update Submit

November 16, 2025

Conditions

ObesityLife Style, HealthyFollow-upGestational Weight GainBody Weight

Outcome Measures

Primary Outcomes (1)

  • Fat mass index , measured by DEXA scan.

    Body composition Assessed by Dual-Energy X-ray Absorptiometry (DEXA). Hologic Horizon, serie number: 301872M. Fat mass, lean mass and bone density will be calculated. Fat mass index in both mothers and offspring (Fat mass index (FMI) defined as: FM (kg) / height (m)2).

    2 years data collection

Secondary Outcomes (24)

  • Glycemic variability

    2 years data collection

  • Mental health

    2 years data collection

  • Diet composition

    2 years data collection

  • Physical activity (PA)

    2 years data collection

  • Puberty stage

    2 years data collection

  • +19 more secondary outcomes

Study Arms (2)

Diet + physical activity

EXPERIMENTAL

Diet + physical activity Dietary advise and advise on physical activity

Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activity

Control group

NO INTERVENTION

No intervention

Interventions

Lifestyle intervention Dietary advise and/or advise on physical activityBEHAVIORAL

Lifestyle intervention Dietary advise and/or advise on physical activity

Diet + physical activity

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers in the initial LiP study selected at the baseline study in 2007-2010
  • Teenagers of mothers in the initial LiP study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Odense

Odense, 5000, Denmark

RECRUITING

Related Publications (1)

  • Luef BM, Jensen NH, Knorr S, Kristensen K, Overgaard M, Stentebjerg LL, Catalano PM, Moller S, Maindal HT, Jensen DM, Vinter CA. Study protocol for a 15-year follow-up of a randomized controlled trial on lifestyle intervention in pregnancy: assessing long-term effects on body composition, metabolic traits, and mental health in mothers and offspring. Trials. 2026 Jan 14. doi: 10.1186/s13063-025-09418-0. Online ahead of print.

    PMID: 41535891DERIVED

MeSH Terms

Conditions

ObesityGestational Weight GainBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWeight GainBody Weight Changes

Study Officials

  • Christina A Vinter, M.D. Ph.D.

    Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina A. Vinter, M.D. Ph.D.

CONTACT

+45 21782118Christina.vinter@rsyd.dk

Birgitte M. Luef, M.D

CONTACT

Birgitte.moller.luef@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Ph.D Student

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 20, 2023

Study Start

October 26, 2023

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)