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NCT Number: NCT01001689

Fit For Delivery: A Study of the Effect of Exercise Sessions and Nutritional Counselling on Pregnancy Outcome

"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.

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Key information

About this study

"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:

  • Affect the amount of weight women gain in pregnancy, and the amount of weight they retain 12 month after delivery
  • 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.
  • Affect the blood sugar level and the incidence of gestational diabetes.
  • Affect the incidence of operative deliveries and the delivery by Cesarean section.
  • Affect the serum concentrations of hormones regulating blood sugar levels, measured in both participants and their newborns.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Maternal weight gain in pregnancy

    Time frame: Measured at the time of delivery

    weight gain in kg

  2. Weight of the newborn

    Time frame: Measured at the time of delivery

    weight in grams at delivery

  3. Maternal fasting serum glucose level

    Time frame: Measured at gestational week 30

    serum glucose

  4. Incidence of operative delivery, both cesarean section and operative vaginal delivery

    Time frame: Assessed following delivery

    number of participants delivered by operative vaginal or cesarean section

  5. Maternal body composition

    Time frame: Measured at 36 weeks of gestation

    Measured using bioimpedance scale

Secondary outcomes

  1. Maternal weight retention

    Time frame: 12 months after delivery

    weight change in kg from pre-pregnancy weight

  2. Measurement of serum levels of hormones which regulate serum glucose levels, in both the pregnant woman and her newborn baby.

    Time frame: Mother measured at gestational week 30, baby measured at delivery

    insulin, leptin

  3. Incidence of women with serum glucose levels >7.8 mmol/l after 2 hour glucose challenge test

    Time frame: Assessed at gestational week 30

    results of glucose challege test

  4. Incidence of delivery complications

    Time frame: Assessed following delivery

    incidence of third and fourth degree tearing, hemmorhage

  5. Proportion of newborns with birth weight over the 90th percentile for gestational age

    Time frame: Assessed following delivery

    weight at gestation, adjusted for population characteristics stratified by sex and gestational age

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.

Acronym: FFF

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Oct 27, 2009
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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