Clinical trial NCT01001689: Fit For Delivery: A Study of the Effect of Exercise Sessions and Nutritional Counselling on Pregnancy Outcome
Official title: Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Obesity
Diabetes
Keywords: Pregnancy
Preventive health care
Fitness
Nutrition
Obesity
Diabetes
Weight gain
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2009-10-27
Enrollment: 606
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: "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.

Detailed description: "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:

* questionaires
* two ultrasound examinations (at 30 and 36 weeks of pregnancy),
* blood tests, including a 2 hour glucose challenge test, and measurement of hormones which regulate blood glucose levels
* weighing of the participant, including use of a bioimpedance scale
* weighing and measuring of her newborn baby,
* blood tests from the umbilical cord, measuring hormones which regulate blood glucose levels
* review of hospital records regarding mode of delivery, delivery complications and possible neonatal admissions for the newborn child.

The investigators' hypothesis is that an intervention in the form of nutritional information and exercise groups will:

1. Affect the amount of weight women gain in pregnancy, and the amount of weight they retain 12 month after delivery
2. Affect the percentage of newborns who have a birthweight over 4 kilo, or who have a birthweight at or above the 90th percentile for Norwegian newborns.
3. Affect the blood sugar level and the incidence of gestational diabetes.
4. Affect the incidence of operative deliveries and the delivery by Cesarean section.
5. Affect the serum concentrations of hormones regulating blood sugar levels, measured in both participants and their newborns.

Eligibility criteria: Inclusion Criteria:

* Expecting first child
* Gestational weeks 12-20
* Residence in one of the following towns: Kristiansand, Søgne, Sogndalen, Vennesla, Lillesand, Mandal

Exclusion Criteria:

* Twin or other multiple pregnancy
* Preexisting diabetes
* Physical handicap which precludes participation in exercise groups
* Ongoing drug addiction
* Serious mental disorder
* BMI at or below 19 before pregnancy
* Inability to read/write Norwegian or English

Primary outcomes:
measure: Maternal weight gain in pregnancy
timeFrame: Measured at the time of delivery
measure: Weight of the newborn
timeFrame: Measured at the time of delivery
measure: Maternal fasting serum glucose level
timeFrame: Measured at gestational week 30
measure: Incidence of operative delivery, both cesarean section and operative vaginal delivery
timeFrame: Assessed following delivery
measure: Maternal body composition
timeFrame: Measured at 36 weeks of gestation
Secondary outcomes:
measure: Maternal weight retention
timeFrame: 12 months after delivery
measure: Measurement of serum levels of hormones which regulate serum glucose levels, in both the pregnant woman and her newborn baby.
timeFrame: Mother measured at gestational week 30, baby measured at delivery
measure: Incidence of women with serum glucose levels >7.8 mmol/l after 2 hour glucose challenge test
timeFrame: Assessed at gestational week 30
measure: Incidence of delivery complications
timeFrame: Assessed following delivery
measure: Proportion of newborns with birth weight over the 90th percentile for gestational age
timeFrame: Assessed following delivery
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
state: Vest Agder
Study officials:
affiliation: Sorland Hospital HF
name: Ingvild Vistad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Oslo, Rikshospital
name: Tore Henriksen, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.