LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-65
SponsorOdense University Hospital
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mothers in the initial LiP study selected at the baseline study in 2007-2010
Teenagers of mothers in the initial LiP study
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle intervention Dietary advise and/or advise on physical activity
BehavioralLifestyle intervention Dietary advise and/or advise on physical activity
Treatment groups
301 Participants
are divided into 2 treatment groupsGroup A: Diet + physical activityExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 collectionSecondary outcomes
1
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 collection2
Mental health
Assessed by questionnaires, validated to mother and child respectively
Time frame
2 years data collection3
Diet composition
Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively
Time frame
2 years data collection4
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 collectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Steno Diabetes Center Odense
Collaborator
University of Southern Denmark
Collaborator
Statens Serum Institut
Collaborator
University of Aarhus
Collaborator
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov