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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01001689
Other study ID # 811363
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date September 2014

Study information

Verified date December 2018
Source Sorlandet Hospital HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 606
Est. completion date September 2014
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nutritional counseling + exercise groups
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.

Locations

Country Name City State
Norway Sorlandet Hospital Kristiansand Vest Agder

Sponsors (1)

Lead Sponsor Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Sagedal LR, Øverby NC, Bere E, Torstveit MK, Lohne-Seiler H, Småstuen 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. — View Citation

Sagedal LR, Sanda B, Øverby 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal weight gain in pregnancy weight gain in kg Measured at the time of delivery
Primary Weight of the newborn weight in grams at delivery Measured at the time of delivery
Primary Maternal fasting serum glucose level serum glucose Measured at gestational week 30
Primary Incidence of operative delivery, both cesarean section and operative vaginal delivery number of participants delivered by operative vaginal or cesarean section Assessed following delivery
Primary Maternal body composition Measured using bioimpedance scale Measured at 36 weeks of gestation
Secondary Maternal weight retention weight change in kg from pre-pregnancy weight 12 months after delivery
Secondary Measurement of serum levels of hormones which regulate serum glucose levels, in both the pregnant woman and her newborn baby. insulin, leptin Mother measured at gestational week 30, baby measured at delivery
Secondary 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
Secondary Incidence of delivery complications incidence of third and fourth degree tearing, hemmorhage Assessed following delivery
Secondary 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
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