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Recruiting NCT05774652

LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

No phase Interventional Obesity Life Style, Healthy Follow-up Gestational Weight Gain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lifestyle intervention Dietary advise and/or advise on physical activity.
Who it may be relevant to
Registry conditions: Obesity, Life Style, Healthy, Follow-up, Gestational Weight Gain. Basic parameters: 13 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

  • Fat mass index , measured by DEXA scan. [Time frame: 2 years data collection]
Secondary outcome measures (12)
  • Glycemic variability [Time frame: 2 years data collection]
  • Mental health [Time frame: 2 years data collection]
  • Diet composition [Time frame: 2 years data collection]
  • Physical activity (PA) [Time frame: 2 years data collection]
  • Puberty stage [Time frame: 2 years data collection]
  • Blood pressure [Time frame: 2 years data collection]
  • Epigenetic examinations [Time frame: 2 years data collection]
  • Metabolic and inflammatory markers [Time frame: 2 years data collection]
  • HbA1c [Time frame: 2 years data collection]
  • Metabolic markers [Time frame: 2 years data collection]
  • Electrolytes [Time frame: 2 years data collection]
  • Insulin [Time frame: 2 years data collection]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Denmark · 1 center
  • Steno Diabetes Center Odense — Odense

Publications

  • 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;27(1):124. doi: 10.1186/s130 PMID 41535891

Identifiers

NCT: NCT05774652 · LiPO-Teen

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗