LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

NCT ID: NCT05774652

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers): Identification of modifiable risk factors for childhood obesity - a follow-up of a randomized controlled trial.

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.

In the original trial women were randomized 1:1 to intervention or control. The participants (both mother and child in pair) who completed the initial LiP study will be invited to a 2-hour examination now 14 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Conditions

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Obesity Life Style, Healthy Follow-up Gestational Weight Gain Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diet + physical activity

Diet + physical activity Dietary advise and advise on physical activity

Group Type EXPERIMENTAL

Lifestyle intervention Dietary advise and/or advise on physical activity

Intervention Type BEHAVIORAL

Lifestyle intervention Dietary advise and/or advise on physical activity

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle intervention Dietary advise and/or advise on physical activity

Lifestyle intervention Dietary advise and/or advise on physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• None
Minimum Eligible Age

13 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Steno Diabetes Center Odense

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Statens Serum Institut

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Birgitte Moeller Luef

M.D, Ph.D Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Steno Diabetes Center Odense

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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

Role: CONTACT

+45 21782118

Birgitte M. Luef, M.D

Role: CONTACT

Facility Contacts

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Christina A Vinter, M.D. PhD.

Role: primary

Birgitte M Luef, M.D

Role: backup

Other Identifiers

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LiPO-Teen

Identifier Type: -

Identifier Source: org_study_id

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