LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Body Weight; Life Style, Healthy; Gestational Weight Gain; Follow-up
• Intervention / Treatment: Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activity

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 Type: Interventional
• Enrollment (Anticipated): 301
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina A. Vinter, M.D. Ph.D.; Phone Number: +45 21782118; Email: Christina.vinter@rsyd.dk
• Study Contact Backup: Name: Birgitte M. Luef, M.D; Email: Birgitte.moller.luef@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Steno Diabetes Center Odense
    • Contact: Christina A Vinter, M.D. PhD.
    • Contact: Birgitte M Luef, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: Diet + physical activity; Diet + physical activity Dietary advise and advise on physical activity	Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activity; Lifestyle intervention Dietary advise and/or advise on physical activity

What is the study measuring?

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
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
Puberty stage	According to the classifications of Marshall and Tanner	2 years data collection
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
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
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
Blood pressure	Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.	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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Aarhus University Hospital; University of Aarhus; University of Southern Denmark; Statens Serum Institut; Steno Diabetes Center Odense
• Investigators: Principal Investigator: Christina A Vinter, M.D. Ph.D., Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight Changes; Obesity; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: LiPO-Teen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No