An interventional study of Lifestyle intervention Dietary advise and/or advise on physical activity in Obesity, Life Style, Healthy and Follow-up, sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 13 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 301 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diet + physical activity Dietary advise and advise on physical activity
Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activity
No intervention
Lifestyle intervention Dietary advise and/or advise on physical activity
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).
Time frame: 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.
Time frame: 2 years data collection
Mental health
Assessed by questionnaires, validated to mother and child respectively
Time frame: 2 years data collection
Diet composition
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Time frame: 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+).
Time frame: 2 years data collection
Puberty stage
According to the classifications of Marshall and Tanner
Time frame: 2 years data collection
Blood pressure
Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.
Time frame: 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).
Time frame: 2 years data collection
Metabolic and inflammatory markers
Blood samples: Glucose
Time frame: 2 years data collection
HbA1c
Blood samples: HbA1c
Time frame: 2 years data collection
Metabolic markers
Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride)
Time frame: 2 years data collection
Electrolytes
Blood sample: Electrolytes
Time frame: 2 years data collection
Insulin
Blood sample: Insulin
Time frame: 2 years data collection
Vitamin D
Blood sample: Vitamin D
Time frame: 2 years data collection
Selenium
Blood sample: Selenium
Time frame: 2 years data collection
Zinc.
Blood sample: Zinc
Time frame: 2 years data collection
C-peptide
Blood sample: C-peptid
Time frame: 2 years data collection
Leptin
Blood sample: Leptin
Time frame: 2 years data collection
Adiponectin
Blood sample: Adiponectin.
Time frame: 2 years data collection
HsCRP.
Blood sample: HsCRP.
Time frame: 2 years data collection
IL6
Blood sample: IL6
Time frame: 2 years data collection
Ferritin
Blood sample: Ferritin
Time frame: 2 years data collection
Leukocytes
Blood sample: Leukocytes
Time frame: 2 years data collection
Kidney function (e-GFR)
Blood sample: Kidney function (e-GFR)
Time frame: 2 years data collection
Liver enzymes
Blood sample: Liver enzymes
Time frame: 2 years data collection
Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for Dec 2025, 25 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 25 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.