Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study

Conditions
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Obesity, Lifestyle, Healthy, Diet, Healthy, Follow-up, Physical Activity, Body Composition, Gestational Weight Gain

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet + physical activity<br>Dietary advise and advise on physical activity monitored by pedometer | Behavioral: Lifestyle intervention<br>* Dietary advise and/or advise on physical activity monitored by pedometer<br>|
| Experimental: Physical activity<br>Advise on physical activity monitored by pedometer | Behavioral: Lifestyle intervention<br>* Dietary advise and/or advise on physical activity monitored by pedometer<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Fatt mass index offspring, DXA scan + BMI mothers | 2 years data collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic and inflammatory markers | Analyses of blood samples | 2 years data collection | 
| Blood pressure | Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures | 2 years data collection | 
| Glycemic variability | CGM measures | 2 years data collection | 
| Mental health | Assessed by questionnaires, validated to mother and child respectively | 2 years data collection | 
| Diet composition | Assessed by FFQ (food frequency questionnaire), validated to mother and child respectively | 2 years data collection | 
| Level and pattern of physical activity | Assessed by activity tracker worn on the rist for 7 days + IPAQ short (International physical activity questionnaire) | 2 years data collection | 
| Relative fitness level | Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test) | 2 years data collection | 
| Epigenetic examinations | Epigenetic examinations | 2 years data collection | 
| Liver stiffness | FibroScan | 2 years data collection | 
| Lung function | Spirometry assessing FVC and FEV1 | 2 years data collection | 
| Large artery stiffness | SphygmoCor examination | 2 years data collection | 
| Eye examination | OPTOS | 2 years data collection | 
| Sex hormones | Analyses of blood samples, children | 2 years data collection | 
| Puberty stage | According to the classifications of Marshall and Tanner | 2 years data collection |