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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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Obesity is a serious and increasing health problem in the Western World with about one third of all pregnant women in Denmark being overweight. Among these are more than 11% severe obese.
Obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. Observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted.
Aims of the trial is to study the effects of diet and physical training during pregnancy among Danish obese women. Also to describe the metabolic effects of lifestyle intervention during pregnancy.
360 obese pregnant women with Body Mass Index (BMI) > 30 are randomized to lifestyle intervention group or control group. The intervention is composed of individual dietician counselling and physical training. The physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups.
Both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. All women receive vitamin supplementation to assure sufficient intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention | Experimental | physical activity, dietetic counselling |
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| Control | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Other | Dietician counselling and physical training |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean Section | At delivery | |
| Preeclampsia/Pregnancy Induced Hypertension | Delivery | |
| Gestational Diabetes Mellitus | Delivery | |
| Large for Gestational Age | Delivery | |
| Neonatal Intensive Care Unit | Within 1 month postpartum | |
| Gestational Weight Gain | Weight at gestational week 35 - weight by inclusion | Gestational week 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Markers | Until 6 months post partum |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina A. Vinter, Ph.d. Student | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense C | DK-5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30061318 | Derived | Vinter CA, Tanvig MH, Christensen MH, Ovesen PG, Jorgensen JS, Andersen MS, McIntyre HD, Jensen DM. Lifestyle Intervention in Danish Obese Pregnant Women With Early Gestational Diabetes Mellitus According to WHO 2013 Criteria Does Not Change Pregnancy Outcomes: Results From the LiP (Lifestyle in Pregnancy) Study. Diabetes Care. 2018 Oct;41(10):2079-2085. doi: 10.2337/dc18-0808. Epub 2018 Jul 30. | |
| 25343235 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Intervention | physical activity, dietetic counselling |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Control |
| Other |
Repeated measuring of maternal weight gain, blood samples and ultrasound |
|
| Physical activity, dietetic counselling | Behavioral | The active intervention consisted of two major components: dietary counseling and physical activity. Dietary counseling was performed by trained dieticians on four separate occasions at 15, 20, 28 and 35 weeks gestation. Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week. |
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| Derived |
| Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Beck-Nielsen H, Christesen HT, Jensen DM. Effects of lifestyle intervention in pregnancy and anthropometrics at birth on offspring metabolic profile at 2.8 years: results from the Lifestyle in Pregnancy and Offspring (LiPO) study. J Clin Endocrinol Metab. 2015 Jan;100(1):175-83. doi: 10.1210/jc.2014-2675. |
| 24989831 | Derived | Vinter CA, Jorgensen JS, Ovesen P, Beck-Nielsen H, Skytthe A, Jensen DM. Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP). Diabet Med. 2014 Nov;31(11):1323-30. doi: 10.1111/dme.12548. Epub 2014 Jul 23. |
| 24834792 | Derived | Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Tanvig M, Lamont RF, Jorgensen JS. Postpartum weight retention and breastfeeding among obese women from the randomized controlled Lifestyle in Pregnancy (LiP) trial. Acta Obstet Gynecol Scand. 2014 Aug;93(8):794-801. doi: 10.1111/aogs.12429. Epub 2014 Jun 13. |
| 24586896 | Derived | Tanvig M, Vinter CA, Jorgensen JS, Wehberg S, Ovesen PG, Lamont RF, Beck-Nielsen H, Christesen HT, Jensen DM. Anthropometrics and body composition by dual energy X-ray in children of obese women: a follow-up of a randomized controlled trial (the Lifestyle in Pregnancy and Offspring [LiPO] study). PLoS One. 2014 Feb 24;9(2):e89590. doi: 10.1371/journal.pone.0089590. eCollection 2014. |
| 21972411 | Derived | Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Jorgensen JS. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women. Diabetes Care. 2011 Dec;34(12):2502-7. doi: 10.2337/dc11-1150. Epub 2011 Oct 4. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Intervention | physical activity, dietetic counselling |
| BG001 | Control | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Age Continuous | Median | Inter-Quartile Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cesarean Section | Not Posted | At delivery | ||||||||||||||||||||||||
| Primary | Preeclampsia/Pregnancy Induced Hypertension | Not Posted | Delivery | ||||||||||||||||||||||||
| Primary | Gestational Diabetes Mellitus | Not Posted | Delivery | ||||||||||||||||||||||||
| Primary | Large for Gestational Age | Not Posted | Delivery | ||||||||||||||||||||||||
| Primary | Neonatal Intensive Care Unit | Not Posted | Within 1 month postpartum | ||||||||||||||||||||||||
| Secondary | Metabolic Markers | Not Posted | Until 6 months post partum | ||||||||||||||||||||||||
| Primary | Gestational Weight Gain | Weight at gestational week 35 - weight by inclusion | Posted | Jul 2011 | Median | Inter-Quartile Range | kg | Gestational week 35 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Intervention | physical activity, dietetic counselling | 0 | 180 | 0 | 180 | ||
| EG001 | Control | 0 | 180 | 0 | 180 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Vinter | Odense University Hospital | +45 21782118 | c.vinter@dadlnet.dk |
| ID | Term |
|---|---|
| D000079262 | Pregnancy in Obesity |
| D000078064 | Gestational Weight Gain |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| >=65 years |
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| Male |
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