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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Statens Serum Institut | OTHER |
| Lund University | OTHER |
| University of Copenhagen |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet + physical activity | Experimental | Dietary advise and advise on physical activity monitored by pedometer |
|
| Physical activity | Experimental | Advise on physical activity monitored by pedometer |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | Dietary advise and/or advise on physical activity monitored by pedometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Fatt mass index offspring, DXA scan + BMI mothers | 2 years data collection |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina M Renault | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
Follow-up study on healthy lifestyle intervention during pregnancy (randomized controlled trial - TOP study) 12 years after the intervention.
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| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |