LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05774652
• Other study ID #: LiPO-Teen
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: January 2023
• Source: Odense University Hospital
• Contact: Christina A. Vinter, M.D. Ph.D.
• Phone: +45 21782118
• Email: Christina.vinter[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 301
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Odense	Odense

Sponsors (6)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital, Statens Serum Institut, Steno Diabetes Center Odense, University of Aarhus, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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