LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

Study Overview
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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.

Official Title
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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

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

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet + physical activity<br>Diet + physical activity Dietary advise and advise on physical activity | Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activity<br>* Lifestyle intervention Dietary advise and/or advise on physical activity<br>|
| No Intervention: Control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic variability | 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 years data collection | 
| Mental health | Assessed by questionnaires, validated to mother and child respectively | 2 years data collection | 
| Diet composition | Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively | 2 years data collection | 
| Physical activity (PA) | Pattern and level of PA will be measured 7 days (24/7) monitored by activity tracker on the wrist (Actigraph GT3X+). | 2 years data collection | 
| Puberty stage | According to the classifications of Marshall and Tanner | 2 years data collection | 
| Blood pressure | Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured. | 2 years data collection | 
| Epigenetic examinations | 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). | 2 years data collection | 
| Metabolic and inflammatory markers | Blood samples: Glucose | 2 years data collection | 
| HbA1c | Blood samples: HbA1c | 2 years data collection | 
| Metabolic markers | Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride) | 2 years data collection | 
| Electrolytes | Blood sample: Electrolytes | 2 years data collection | 
| Insulin | Blood sample: Insulin | 2 years data collection | 
| Vitamin D | Blood sample: Vitamin D | 2 years data collection | 
| Selenium | Blood sample: Selenium | 2 years data collection | 
| Zinc. | Blood sample: Zinc | 2 years data collection | 
| C-peptide | Blood sample: C-peptid | 2 years data collection | 
| Leptin | Blood sample: Leptin | 2 years data collection | 
| Adiponectin | Blood sample: Adiponectin. | 2 years data collection | 
| HsCRP. | Blood sample: HsCRP. | 2 years data collection | 
| IL6 | Blood sample: IL6 | 2 years data collection | 
| Ferritin | Blood sample: Ferritin | 2 years data collection | 
| Leukocytes | Blood sample: Leukocytes | 2 years data collection | 
| Kidney function (e-GFR) | Blood sample: Kidney function (e-GFR) | 2 years data collection | 
| Liver enzymes | Blood sample: Liver enzymes | 2 years data collection |