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NCT Number: NCT05774652

LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Follow-up Gestational Weight Gain Life Style, Healthy Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Odense

Odense, 5000, Denmark

Location status: Recruiting

Location contact

Birgitte M Luef, M.D

CONTACT

Christina A Vinter, M.D. PhD.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle intervention Dietary advise and/or advise on physical activity

Behavioral

Lifestyle intervention Dietary advise and/or advise on physical activity

Primary outcomes

  1. Fat mass index , measured by DEXA scan.

    Time frame: 2 years data collection

    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).

Secondary outcomes

  1. Glycemic variability

    Time frame: 2 years data collection

    Continuous glucose monitoring (CGM, DEXCOM G6Pro): 10 days recording of fasting glucose and postprandial glucose values. Glucose variability will be assessed using a device, which performs repeated glucose measurements in the skin providing insights into glucose fluctuations throughout the day and night.

  2. Mental health

    Time frame: 2 years data collection

    Assessed by questionnaires, validated to mother and child respectively

  3. Diet composition

    Time frame: 2 years data collection

    Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively

  4. Physical activity (PA)

    Time frame: 2 years data collection

    Pattern and level of PA will be measured 7 days (24/7) monitored by activity tracker on the wrist (Actigraph GT3X+).

  5. Puberty stage

    Time frame: 2 years data collection

    According to the classifications of Marshall and Tanner

  6. Blood pressure

    Time frame: 2 years data collection

    Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.

  7. Epigenetic examinations

    Time frame: 2 years data collection

    Blood samples:

    The epigenetic profile of DNA samples extracted from whole blood will be characterized by Genome-wide DNA methylation using Infinium MethylationEPIC v2.0 Kit. Principle component and hierarchical clustering analyses will be used to identify associations between methylation patterns and a range of clinical characteristics, biomarkers as well as gene expression levels (RNAseq).

  8. Metabolic and inflammatory markers

    Time frame: 2 years data collection

    Blood samples: Glucose

  9. HbA1c

    Time frame: 2 years data collection

    Blood samples: HbA1c

  10. Metabolic markers

    Time frame: 2 years data collection

    Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride)

  11. Electrolytes

    Time frame: 2 years data collection

    Blood sample: Electrolytes

  12. Insulin

    Time frame: 2 years data collection

    Blood sample: Insulin

  13. Vitamin D

    Time frame: 2 years data collection

    Blood sample: Vitamin D

  14. Selenium

    Time frame: 2 years data collection

    Blood sample: Selenium

  15. Zinc.

    Time frame: 2 years data collection

    Blood sample: Zinc

  16. C-peptide

    Time frame: 2 years data collection

    Blood sample: C-peptid

  17. Leptin

    Time frame: 2 years data collection

    Blood sample: Leptin

  18. Adiponectin

    Time frame: 2 years data collection

    Blood sample: Adiponectin.

  19. HsCRP.

    Time frame: 2 years data collection

    Blood sample: HsCRP.

  20. IL6

    Time frame: 2 years data collection

    Blood sample: IL6

  21. Ferritin

    Time frame: 2 years data collection

    Blood sample: Ferritin

  22. Leukocytes

    Time frame: 2 years data collection

    Blood sample: Leukocytes

  23. Kidney function (e-GFR)

    Time frame: 2 years data collection

    Blood sample: Kidney function (e-GFR)

  24. Liver enzymes

    Time frame: 2 years data collection

    Blood sample: Liver enzymes

Study contacts

Contact information is provided by the study sponsor or research team.

Birgitte M. Luef, M.D

CONTACT

[email protected]

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

CONTACT

[email protected]

+45 21782118

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Statens Serum Institut
  • Steno Diabetes Center Odense
  • University of Aarhus
  • University of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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