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Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.
Obese pregnant women with a BMI>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.
The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet + Exercise | Experimental | Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling |
|
| Exercise | Experimental | Exercise: Individual counselling |
|
| Control | No Intervention | Standard treatment without intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet + Exercise | Behavioral | Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician. Exercise: Individual counselling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal weight gain | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy complications | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 | |
| Glucose tolerance in pregnancy | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Jørgen Secher, Professor | Department of Obstetrics and Gynecology, Hvidovre University Hospital | Study Chair |
| Lisbeth Nilas, Prof. DMSc | Department of Obstetrics and Gynecology, Hvidovre University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Hvidovre University Hospital | Copenhagen | DK-2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26561621 | Derived | Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Cortes D, Jensen JE, Olsen SF, Halldorsson TI. Intake of carbohydrates during pregnancy in obese women is associated with fat mass in the newborn offspring. Am J Clin Nutr. 2015 Dec;102(6):1475-81. doi: 10.3945/ajcn.115.110551. Epub 2015 Nov 11. | |
| 26192183 | Derived |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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|
| Birth weight | At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012 |
| Renault KM, Carlsen EM, Norgaard K, Nilas L, Pryds O, Secher NJ, Olsen SF, Halldorsson TI. Intake of Sweets, Snacks and Soft Drinks Predicts Weight Gain in Obese Pregnant Women: Detailed Analysis of the Results of a Randomised Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0133041. doi: 10.1371/journal.pone.0133041. eCollection 2015. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |