LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

Not Applicable

Recruiting

• Conditions: Obesity; Gestational Weight Gain; Follow-up; Life Style, Healthy; Body Weight
• Interventions: Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activity

• Registration Number: NCT05774652
• Lead Sponsor: Odense University Hospital

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.

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.

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-20
• Study Start: 2023-10-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-12-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet + physical activity	Lifestyle intervention Dietary advise and/or advise on physical activity	Diet + physical activity Dietary advise and advise on physical activity

Primary Outcome Measures

Name	Time	Method
Fat mass index , measured by DEXA scan.	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 Outcome Measures

Name	Time	Method
Vitamin D	2 years data collection	Blood sample: Vitamin D
Electrolytes	2 years data collection	Blood sample: Electrolytes
Insulin	2 years data collection	Blood sample: Insulin
C-peptide	2 years data collection	Blood sample: C-peptid
Adiponectin	2 years data collection	Blood sample: Adiponectin.
Leukocytes	2 years data collection	Blood sample: Leukocytes
Kidney function (e-GFR)	2 years data collection	Blood sample: Kidney function (e-GFR)
Blood pressure	2 years data collection	Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.
Metabolic markers	2 years data collection	Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride)
Diet composition	2 years data collection	Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Physical activity (PA)	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+).
Epigenetic examinations	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).
Metabolic and inflammatory markers	2 years data collection	Blood samples: Glucose
Glycemic variability	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.
Mental health	2 years data collection	Assessed by questionnaires, validated to mother and child respectively
Puberty stage	2 years data collection	According to the classifications of Marshall and Tanner
Leptin	2 years data collection	Blood sample: Leptin
HsCRP.	2 years data collection	Blood sample: HsCRP.
IL6	2 years data collection	Blood sample: IL6
Selenium	2 years data collection	Blood sample: Selenium
Zinc.	2 years data collection	Blood sample: Zinc
Ferritin	2 years data collection	Blood sample: Ferritin
Liver enzymes	2 years data collection	Blood sample: Liver enzymes
HbA1c	2 years data collection	Blood samples: HbA1c

Trial Locations

Locations (1)

Steno Diabetes Center Odense; 🇩🇰 Odense, Denmark