Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Steno Diabetes Center Odense | OTHER |
| University of Southern Denmark | OTHER |
| Statens Serum Institut | OTHER |
| University of Aarhus |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet + physical activity | Experimental | Diet + physical activity Dietary advise and advise on physical activity |
|
| Control group | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention Dietary advise and/or advise on physical activity | Behavioral | Lifestyle intervention Dietary advise and/or advise on physical activity |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• None
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina A. Vinter, M.D. Ph.D. | Contact | +45 21782118 | Christina.vinter@rsyd.dk | |
| Birgitte M. Luef, M.D | Contact | Birgitte.moller.luef@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Christina A Vinter, M.D. Ph.D. | Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Odense | Recruiting | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41535891 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000078064 | Gestational Weight Gain |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| OTHER |
| Aarhus University Hospital | OTHER |
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.
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| Puberty stage | According to the classifications of Marshall and Tanner | 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 |
| 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 |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |