Clinical trial NCT05774652: LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Life Style, Healthy
Follow-up
Gestational Weight Gain
Body Weight
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Odense
name: University of Southern Denmark
name: Statens Serum Institut
name: University of Aarhus
name: Aarhus University Hospital
First posted: 2023-03-20
Enrollment: 301
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Fat mass index , measured by DEXA scan.
timeFrame: 2 years data collection
Secondary outcomes:
measure: Glycemic variability
timeFrame: 2 years data collection
measure: Mental health
timeFrame: 2 years data collection
measure: Diet composition
timeFrame: 2 years data collection
measure: Physical activity (PA)
timeFrame: 2 years data collection
measure: Puberty stage
timeFrame: 2 years data collection
measure: Blood pressure
timeFrame: 2 years data collection
measure: Epigenetic examinations
timeFrame: 2 years data collection
measure: Metabolic and inflammatory markers
timeFrame: 2 years data collection
measure: HbA1c
timeFrame: 2 years data collection
measure: Metabolic markers
timeFrame: 2 years data collection
measure: Electrolytes
timeFrame: 2 years data collection
measure: Insulin
timeFrame: 2 years data collection
measure: Vitamin D
timeFrame: 2 years data collection
measure: Selenium
timeFrame: 2 years data collection
measure: Zinc.
timeFrame: 2 years data collection
measure: C-peptide
timeFrame: 2 years data collection
measure: Leptin
timeFrame: 2 years data collection
measure: Adiponectin
timeFrame: 2 years data collection
measure: HsCRP.
timeFrame: 2 years data collection
measure: IL6
timeFrame: 2 years data collection
measure: Ferritin
timeFrame: 2 years data collection
measure: Leukocytes
timeFrame: 2 years data collection
measure: Kidney function (e-GFR)
timeFrame: 2 years data collection
measure: Liver enzymes
timeFrame: 2 years data collection
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Steno Diabetes Center Odense
Study officials:
affiliation: Department of Gynecology and Obstetrics. Odense University Hospital. University of Southern Denmark
name: Christina A Vinter, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: