Clinical trial NCT05446220: Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
Official title: Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lifestyle, Healthy
Diet, Healthy
Follow-up
Physical Activity
Body Composition
Gestational Weight Gain
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Statens Serum Institut
name: Lund University
name: University of Copenhagen
First posted: 2022-07-06
Enrollment: 260
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
Primary purpose: PREVENTION

Brief summary: The participant (both mother and child) in the initial TOP study will be invited to a follow-up study to evaluate the effect of life style intervention during pregnancy on both mother and their offspring 12 years after the intervention. The study will contribute to understanding the transfer of obesity between generations and how to treat as well as prevent obesity.

Detailed description: The initial study (Treatment of Obese Pregnant women (TOP) study) was performed at Hvidovre Hospital, University of Copenhagen in 2009-12 and included 425 pregnant women with pre-gestational BMI ≥ 30kg/m2 in gestational week 11-14. They were randomized 1:1:1 into: 1) a low-calorie Mediterranean-style diet and pedometer assisted physical activity (PA) intervention 2) a pedometer assisted PA intervention alone or 3) no intervention (control). Primary outcome was gestational weight gain (GWG). 389 women completed the study.

The participants (both mother and child in pair) who completed the initial TOP study will be invited to a 3-hour examination now 12 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Eligibility criteria: Inclusion Criteria:

* Participants/mothers in the initial TOP study will be invited with their offspring born following the pregnancy during the initial study to the 12-year follow-up study

Exclusion Criteria:

* There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012

Primary outcomes:
measure: Body composition
timeFrame: 2 years data collection
Secondary outcomes:
measure: Metabolic and inflammatory markers
timeFrame: 2 years data collection
measure: Blood pressure
timeFrame: 2 years data collection
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: Level and pattern of physical activity
timeFrame: 2 years data collection
measure: Relative fitness level
timeFrame: 2 years data collection
measure: Epigenetic examinations
timeFrame: 2 years data collection
measure: Liver stiffness
timeFrame: 2 years data collection
measure: Lung function
timeFrame: 2 years data collection
measure: Large artery stiffness
timeFrame: 2 years data collection
measure: Eye examination
timeFrame: 2 years data collection
measure: Sex hormones
timeFrame: 2 years data collection
measure: Puberty stage
timeFrame: 2 years data collection
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kristina M Renault
role: PRINCIPAL_INVESTIGATOR
References: