Body Weight, Follow-up, Gestational Weight Gain, Life Style, Healthy, Obesity
Conditions
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.
Interventions
BEHAVIORALLifestyle intervention Dietary advise and/or advise on physical activity
Lifestyle intervention Dietary advise and/or advise on physical activity
Sponsors
Steno Diabetes Center Odense
University of Southern Denmark
Statens Serum Institut
University of Aarhus
Aarhus University Hospital
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Vitamin D | 2 years data collection | Blood sample: Vitamin D |
| 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 |
| 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. |
Countries
Denmark
Contacts
Primary ContactChristina A. Vinter, M.D. Ph.D.
Backup ContactBirgitte M. Luef, M.D
Outcome results
None listed