Body Composition, Diet, Healthy, Follow-up, Gestational Weight Gain, Lifestyle, Healthy, Obesity, Physical Activity
Conditions
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.
Interventions
BEHAVIORALLifestyle intervention
Dietary advise and/or advise on physical activity monitored by pedometer
Sponsors
Rigshospitalet, Denmark
Statens Serum Institut
Lund University
University of Copenhagen
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 2 years data collection | Fatt mass index offspring, DXA scan + BMI mothers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 2 years data collection | Standardized sitting measurement of systolic and diastolic blood pressure, average of 3 measures |
| Glycemic variability | 2 years data collection | CGM measures |
| 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 |
| Level and pattern of physical activity | 2 years data collection | Assessed by activity tracker worn on the rist for 7 days + IPAQ short (International physical activity questionnaire) |
| Relative fitness level | 2 years data collection | Estimated relative fitness level assessed by a submaximal step test (The Danish Step Test) |
| Metabolic and inflammatory markers | 2 years data collection | Analyses of blood samples |
| Liver stiffness | 2 years data collection | FibroScan |
| Lung function | 2 years data collection | Spirometry assessing FVC and FEV1 |
| Large artery stiffness | 2 years data collection | SphygmoCor examination |
| Eye examination | 2 years data collection | OPTOS |
| Sex hormones | 2 years data collection | Analyses of blood samples, children |
| Puberty stage | 2 years data collection | According to the classifications of Marshall and Tanner |
| Epigenetic examinations | 2 years data collection | Epigenetic examinations |
Countries
Denmark
Outcome results
None listed