ObesityNCT05774652
LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers
A study testing Lifestyle intervention Dietary advise and/or advise on physical activity in people with Obesity and Life Style, Healthy, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Life Style, Healthy, Follow-up
- What is being tested?
- Lifestyle intervention Dietary advise and/or advise on physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Oct 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers in the initial LiP study selected at the baseline study in 2007-2010
- Teenagers of mothers in the initial LiP study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Birgitte M. Luef, M.D contact
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Odense
Odense, 5000
Christina A Vinter, M.D. PhD.
Birgitte M Luef, M.D
About this study
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
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.
Read the 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.
- Conditions
- Obesity, Life Style, Healthy, Follow-up, Gestational Weight Gain, Body Weight
- Being tested
- Lifestyle intervention Dietary advise and/or advise on physical activity
- Medical subject headings
- Obesity, Gestational Weight Gain, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention Dietary advise and/or advise on physical activityBehavioural
Lifestyle intervention Dietary advise and/or advise on physical activity
| Study group | Role | What they receive |
|---|---|---|
| Diet + physical activity | Experimental | Diet + physical activity Dietary advise and advise on physical activity Receives: Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activity |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years data collection
Secondary outcomes (24)
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.
Measured: 2 years data collection
Mental health
Assessed by questionnaires, validated to mother and child respectively
Measured: 2 years data collection
Diet composition
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Measured: 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+).
Measured: 2 years data collection
Puberty stage
According to the classifications of Marshall and Tanner
Measured: 2 years data collection
Blood pressure
Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.
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).
Measured: 2 years data collection
Metabolic and inflammatory markers
Blood samples: Glucose
Measured: 2 years data collection
HbA1c
Blood samples: HbA1c
Measured: 2 years data collection
Metabolic markers
Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride)
Measured: 2 years data collection
Electrolytes
Blood sample: Electrolytes
Measured: 2 years data collection
Insulin
Blood sample: Insulin
Measured: 2 years data collection
Vitamin D
Blood sample: Vitamin D
Measured: 2 years data collection
Selenium
Blood sample: Selenium
Measured: 2 years data collection
Zinc.
Blood sample: Zinc
Measured: 2 years data collection
C-peptide
Blood sample: C-peptid
Measured: 2 years data collection
Leptin
Blood sample: Leptin
Measured: 2 years data collection
Adiponectin
Blood sample: Adiponectin.
Measured: 2 years data collection
HsCRP.
Blood sample: HsCRP.
Measured: 2 years data collection
IL6
Blood sample: IL6
Measured: 2 years data collection
Ferritin
Blood sample: Ferritin
Measured: 2 years data collection
Leukocytes
Blood sample: Leukocytes
Measured: 2 years data collection
Kidney function (e-GFR)
Blood sample: Kidney function (e-GFR)
Measured: 2 years data collection
Liver enzymes
Blood sample: Liver enzymes
Measured: 2 years data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start26 Oct 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 301 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Odense, University of Southern Denmark, Statens Serum Institut, University of Aarhus, Aarhus University Hospital
- Responsible party
- Principal investigator, Birgitte Moeller Luef, Odense University Hospital
- Investigators
- Christina A Vinter, M.D. Ph.D., Principal investigator, Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774652
- Sponsor's protocol ID
- LiPO-Teen
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luef BM, Jensen NH, Knorr S, Kristensen K, Overgaard M, Stentebjerg LL, Catalano PM, Moller S, Maindal HT, Jensen DM, Vinter CA. Study protocol for a 15-year follow-up of a randomized controlled trial on lifestyle intervention in pregnancy: assessing long-term effects on body composition, metabolic traits, and mental health in mothers and offspring. Trials. 2026 Jan 14;27(1):124. doi: 10.1186/s13063-025-09418-0.
PubMed 41535891
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05774652
- Acronym / sponsor ID
- LiPO-Teen
- Conditions
- Obesity, Life Style, Healthy, Follow-up, Gestational Weight Gain, Body Weight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 301 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Odense, University of Southern Denmark, Statens Serum Institut, University of Aarhus, Aarhus University Hospital
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet + physical activity | Experimental | Behavioral: Lifestyle intervention Dietary advise and/or advise on physical activityDiet + physical activity Dietary advise and advise on physical activity |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mothers in the initial LiP study selected at the baseline study in 2007-2010
- Teenagers of mothers in the initial LiP study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention Dietary advise and/or advise on physical activityLifestyle intervention Dietary advise and/or advise on physical activity | Behavioural | Diet + physical activity |
Primary outcome
Fat mass index , measured by DEXA scan.
Time frame: 2 years data collection
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).
24 secondary outcomes
Glycemic variability
Time frame: 2 years data collection
Mental health
Time frame: 2 years data collection
Diet composition
Time frame: 2 years data collection
Physical activity (PA)
Time frame: 2 years data collection
Puberty stage
Time frame: 2 years data collection
Blood pressure
Time frame: 2 years data collection
Epigenetic examinations
Time frame: 2 years data collection
Metabolic and inflammatory markers
Time frame: 2 years data collection
HbA1c
Time frame: 2 years data collection
Metabolic markers
Time frame: 2 years data collection
Electrolytes
Time frame: 2 years data collection
Insulin
Time frame: 2 years data collection
Vitamin D
Time frame: 2 years data collection
Selenium
Time frame: 2 years data collection
Zinc.
Time frame: 2 years data collection
C-peptide
Time frame: 2 years data collection
Leptin
Time frame: 2 years data collection
Adiponectin
Time frame: 2 years data collection
HsCRP.
Time frame: 2 years data collection
IL6
Time frame: 2 years data collection
Ferritin
Time frame: 2 years data collection
Leukocytes
Time frame: 2 years data collection
Kidney function (e-GFR)
Time frame: 2 years data collection
Liver enzymes
Time frame: 2 years data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 41535891Luef BM, Jensen NH, Knorr S, Kristensen K, Overgaard M, Stentebjerg LL, Catalano PM, Moller S, Maindal HT, Jensen DM, Vinter CA. Study protocol for a 15-year follow-up of a randomized controlled trial on lifestyle intervention in pregnancy: assessing long-term effects on body composition, metabolic traits, and mental health in mothers and offspring. Trials. 2026 Jan 14;27(1):124. doi: 10.1186/s13063-025-09418-0.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgitte M. Luef, M.D contact
Christina A Vinter, M.D. Ph.D. principal investigator
Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention Dietary advise and/or advise on physical activity in people with Obesity and Life Style, Healthy, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina A. Vinter, M.D. Ph.D. (+45 21782118, Christina.vinter@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass index , measured by DEXA scan. (time frame: 2 years data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.