LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
| No Intervention: Control group No intervention |
Outcome Measures
Primary Outcome Measures
- Fat mass index , measured by DEXA scan. [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).
Secondary Outcome Measures
- Glycemic variability [2 years data collection]
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 [2 years data collection]
Assessed by questionnaires, validated to mother and child respectively
- Diet composition [2 years data collection]
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
- Physical activity (PA) [2 years data collection]
Pattern and level of PA will be measured 7 days (24/7) monitored by activity tracker on the wrist (Actigraph GT3X+).
- Puberty stage [2 years data collection]
According to the classifications of Marshall and Tanner
- Blood pressure [2 years data collection]
Standardized sitting measurement, average of 3 measures. Both systolic and diastolic blood pressure will be measured.
- Epigenetic examinations [2 years data collection]
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 [2 years data collection]
Blood samples: Glucose
- HbA1c [2 years data collection]
Blood samples: HbA1c
- Metabolic markers [2 years data collection]
Blood samples: Lipids (total cholesterol, HDL, LDL, triglyceride)
- Electrolytes [2 years data collection]
Blood sample: Electrolytes
- Insulin [2 years data collection]
Blood sample: Insulin
- Vitamin D [2 years data collection]
Blood sample: Vitamin D
- Selenium [2 years data collection]
Blood sample: Selenium
- Zinc. [2 years data collection]
Blood sample: Zinc
- C-peptide [2 years data collection]
Blood sample: C-peptid
- Leptin [2 years data collection]
Blood sample: Leptin
- Adiponectin [2 years data collection]
Blood sample: Adiponectin.
- HsCRP. [2 years data collection]
Blood sample: HsCRP.
- IL6 [2 years data collection]
Blood sample: IL6
- Ferritin [2 years data collection]
Blood sample: Ferritin
- Leukocytes [2 years data collection]
Blood sample: Leukocytes
- Kidney function (e-GFR) [2 years data collection]
Blood sample: Kidney function (e-GFR)
- Liver enzymes [2 years data collection]
Blood sample: Liver enzymes
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Steno Diabetes Center Odense | Odense | Denmark | 5000 |
Sponsors and Collaborators
- Odense University Hospital
- Steno Diabetes Center Odense
- Aarhus University Hospital
- University of Aarhus
- University of Southern Denmark
- Statens Serum Institut
Investigators
- Principal Investigator: Christina A Vinter, M.D. Ph.D., Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LiPO-Teen