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"Fit for Delivery" is a randomized, controlled study to examine the effects of an intervention during pregnancy which consists of exercise groups and nutritional counselling. The investigators will assess the outcomes of gestational weight gain, postpartum weight retention, large newborns, glucose regulation, and the incidence of complications of pregnancy and delivery such as gestational diabetes and Cesarean section.
"Fit for Delivery" is a randomized, controlled study to examine the effects of an intervention during pregnancy which consists of exercise groups and nutritional counselling. The investigators intend to study 600 women who are expecting their first child, and include them in the study at the time of their first appointment at their local healthcare clinic, when they are between 12 and 20 weeks of pregnancy. All women who wish to participate will sign an informed consent.
Women who are randomly assigned to the intervention group will receive two telephone consultations with nutritional advice on healthy eating during pregnancy. They will also be counselled about appropriate weight gain during pregnancy given their pre-pregnancy body mass index. They will be assigned to an exercise group which will meet twice a week for a specially designed workout, and will be encouraged to exercise once or twice weekly on their own. Women in the intervention group will also have access to a password-protected internet site with information on healthy living during pregnancy, and be invited to 2 or 3 evening classes with nutritional information. Women who are randomly assigned to the control group will receive routine pregnancy care.
All women in the study will be studied using:
The investigators' hypothesis is that an intervention in the form of nutritional information and exercise groups will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional counseling + exercise groups | Experimental | Women in this arm will receive 2 telephone consultations on nutritional health during pregnancy, be invited to 2 evening meetings with nutritional topics and have access to a password protected internet site with topics related to nutrition and fitness in pregnancy. They will also be enrolled in an exercise group which will meet twice weekly, and be encouraged to exercise on their own 1-2 times each week. |
|
| control | No Intervention | Women in this arm of the study will receive routine pregnancy care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional counseling + exercise groups | Behavioral | Two telephone consultations on nutritional topics and twice weekly exercise groups. Access to a password-protected internet site with information on healthy lifestyle during pregnancy. Two evening meetings with information on healthy pregnancy lifestyle. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal weight gain in pregnancy | weight gain in kg | Measured at the time of delivery |
| Weight of the newborn | weight in grams at delivery | Measured at the time of delivery |
| Maternal fasting serum glucose level | serum glucose | Measured at gestational week 30 |
| Incidence of operative delivery, both cesarean section and operative vaginal delivery | number of participants delivered by operative vaginal or cesarean section | Assessed following delivery |
| Maternal body composition | Measured using bioimpedance scale | Measured at 36 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal weight retention | weight change in kg from pre-pregnancy weight | 12 months after delivery |
| Measurement of serum levels of hormones which regulate serum glucose levels, in both the pregnant woman and her newborn baby. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingvild Vistad, MD, PhD | Sorland Hospital HF | Principal Investigator |
| Tore Henriksen, MD, PhD | University Hospital of Oslo, Rikshospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorlandet Hospital | Kristiansand | Vest Agder | 4604 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26768233 | Background | Sagedal LR, Overby NC, Bere E, Torstveit MK, Lohne-Seiler H, Smastuen M, Hillesund ER, Henriksen T, Vistad I. Lifestyle intervention to limit gestational weight gain: the Norwegian Fit for Delivery randomised controlled trial. BJOG. 2017 Jan;124(1):97-109. doi: 10.1111/1471-0528.13862. Epub 2016 Jan 14. | |
| 26786294 | Background |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
insulin, leptin
| Mother measured at gestational week 30, baby measured at delivery |
| Incidence of women with serum glucose levels >7.8 mmol/l after 2 hour glucose challenge test | results of glucose challege test | Assessed at gestational week 30 |
| Incidence of delivery complications | incidence of third and fourth degree tearing, hemmorhage | Assessed following delivery |
| Proportion of newborns with birth weight over the 90th percentile for gestational age | weight at gestation, adjusted for population characteristics stratified by sex and gestational age | Assessed following delivery |
| Sagedal LR, Sanda B, Overby NC, Bere E, Torstveit MK, Lohne-Seiler H, Hillesund ER, Pripp AH, Henriksen T, Vistad I. The effect of prenatal lifestyle intervention on weight retention 12 months postpartum: results of the Norwegian Fit for Delivery randomised controlled trial. BJOG. 2017 Jan;124(1):111-121. doi: 10.1111/1471-0528.13863. Epub 2016 Jan 20. |
| 29739447 | Derived | Hillesund ER, Seland S, Bere E, Sagedal LR, Torstveit MK, Lohne-Seiler H, Vistad I, Overby NC. Preeclampsia and gestational weight gain in the Norwegian Fit for Delivery trial. BMC Res Notes. 2018 May 8;11(1):282. doi: 10.1186/s13104-018-3396-4. |
| 29724165 | Derived | Haakstad LAH, Vistad I, Sagedal LR, Lohne-Seiler H, Torstveit MK. How does a lifestyle intervention during pregnancy influence perceived barriers to leisure-time physical activity? The Norwegian fit for delivery study, a randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 3;18(1):127. doi: 10.1186/s12884-018-1771-8. |
| 28577545 | Derived | Sagedal LR, Vistad I, Overby NC, Bere E, Torstveit MK, Lohne-Seiler H, Hillesund ER, Pripp A, Henriksen T. The effect of a prenatal lifestyle intervention on glucose metabolism: results of the Norwegian Fit for Delivery randomized controlled trial. BMC Pregnancy Childbirth. 2017 Jun 2;17(1):167. doi: 10.1186/s12884-017-1340-6. |
| 28376732 | Derived | Skreden M, Bere E, Sagedal LR, Vistad I, Overby NC. Changes in fruit and vegetable consumption habits from pre-pregnancy to early pregnancy among Norwegian women. BMC Pregnancy Childbirth. 2017 Apr 4;17(1):107. doi: 10.1186/s12884-017-1291-y. |
| 23406306 | Derived | Sagedal LR, Overby NC, Lohne-Seiler H, Bere E, Torstveit MK, Henriksen T, Vistad I. Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial. BMC Public Health. 2013 Feb 13;13:132. doi: 10.1186/1471-2458-13-132. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |