LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers
Primary Purpose
Obesity, Life Style, Healthy, Follow-up
Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle intervention Dietary advise and/or advise on physical activity
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Steno Diabetes Center Odense
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Diet + physical activity
Control group
Arm Description
Diet + physical activity Dietary advise and advise on physical activity
No intervention
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Mental health
Assessed by questionnaires, validated to mother and child respectively
Diet composition
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Physical activity (PA)
Pattern and level of PA will be measured 7 days (24/7) monitored by activity tracker on the wrist (Actigraph GT3X+).
Puberty stage
According to the classifications of Marshall and Tanner
Blood pressure
Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.
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).
Metabolic and inflammatory markers
Blood samples: Glucose
HbA1c
Blood samples: HbA1c
Metabolic markers
Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride)
Electrolytes
Blood sample: Electrolytes
Insulin
Blood sample: Insulin
Vitamin D
Blood sample: Vitamin D
Selenium
Blood sample: Selenium
Zinc.
Blood sample: Zinc
C-peptide
Blood sample: C-peptid
Leptin
Blood sample: Leptin
Adiponectin
Blood sample: Adiponectin.
HsCRP.
Blood sample: HsCRP.
IL6
Blood sample: IL6
Ferritin
Blood sample: Ferritin
Leukocytes
Blood sample: Leukocytes
Kidney function (e-GFR)
Blood sample: Kidney function (e-GFR)
Liver enzymes
Blood sample: Liver enzymes
Full Information
NCT ID
NCT05774652
First Posted
February 16, 2023
Last Updated
March 21, 2023
Sponsor
Odense University Hospital
Collaborators
Steno Diabetes Center Odense, Aarhus University Hospital, University of Aarhus, University of Southern Denmark, Statens Serum Institut
1. Study Identification
Unique Protocol Identification Number
NCT05774652
Brief Title
LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Odense University Hospital
Collaborators
Steno Diabetes Center Odense, Aarhus University Hospital, University of Aarhus, University of Southern Denmark, Statens Serum Institut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Life Style, Healthy, Follow-up, Gestational Weight Gain, Body Weight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
301 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet + physical activity
Arm Type
Experimental
Arm Description
Diet + physical activity Dietary advise and advise on physical activity
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention Dietary advise and/or advise on physical activity
Intervention Description
Lifestyle intervention Dietary advise and/or advise on physical activity
Primary Outcome Measure Information:
Title
Fat mass index , measured by DEXA scan.
Description
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).
Time Frame
2 years data collection
Secondary Outcome Measure Information:
Title
Glycemic variability
Description
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.
Time Frame
2 years data collection
Title
Mental health
Description
Assessed by questionnaires, validated to mother and child respectively
Time Frame
2 years data collection
Title
Diet composition
Description
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Time Frame
2 years data collection
Title
Physical activity (PA)
Description
Pattern and level of PA will be measured 7 days (24/7) monitored by activity tracker on the wrist (Actigraph GT3X+).
Time Frame
2 years data collection
Title
Puberty stage
Description
According to the classifications of Marshall and Tanner
Time Frame
2 years data collection
Title
Blood pressure
Description
Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.
Time Frame
2 years data collection
Title
Epigenetic examinations
Description
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).
Time Frame
2 years data collection
Title
Metabolic and inflammatory markers
Description
Blood samples: Glucose
Time Frame
2 years data collection
Title
HbA1c
Description
Blood samples: HbA1c
Time Frame
2 years data collection
Title
Metabolic markers
Description
Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride)
Time Frame
2 years data collection
Title
Electrolytes
Description
Blood sample: Electrolytes
Time Frame
2 years data collection
Title
Insulin
Description
Blood sample: Insulin
Time Frame
2 years data collection
Title
Vitamin D
Description
Blood sample: Vitamin D
Time Frame
2 years data collection
Title
Selenium
Description
Blood sample: Selenium
Time Frame
2 years data collection
Title
Zinc.
Description
Blood sample: Zinc
Time Frame
2 years data collection
Title
C-peptide
Description
Blood sample: C-peptid
Time Frame
2 years data collection
Title
Leptin
Description
Blood sample: Leptin
Time Frame
2 years data collection
Title
Adiponectin
Description
Blood sample: Adiponectin.
Time Frame
2 years data collection
Title
HsCRP.
Description
Blood sample: HsCRP.
Time Frame
2 years data collection
Title
IL6
Description
Blood sample: IL6
Time Frame
2 years data collection
Title
Ferritin
Description
Blood sample: Ferritin
Time Frame
2 years data collection
Title
Leukocytes
Description
Blood sample: Leukocytes
Time Frame
2 years data collection
Title
Kidney function (e-GFR)
Description
Blood sample: Kidney function (e-GFR)
Time Frame
2 years data collection
Title
Liver enzymes
Description
Blood sample: Liver enzymes
Time Frame
2 years data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina A. Vinter, M.D. Ph.D.
Phone
+45 21782118
Email
Christina.vinter@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitte M. Luef, M.D
Email
Birgitte.moller.luef@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina A Vinter, M.D. Ph.D.
Organizational Affiliation
Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Odense
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina A Vinter, M.D. PhD.
First Name & Middle Initial & Last Name & Degree
Birgitte M Luef, M.D
12. IPD Sharing Statement
Plan to Share IPD
No
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LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers
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