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PregnancyFFFNCT01001689

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

A study testing Nutritional counseling + exercise groups in people with Pregnancy and Obesity, run by Sorlandet Hospital HF at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Pregnancy, Obesity, Diabetes
What is being tested?
Nutritional counseling + exercise groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
606 participants
Where
1 siteNorway
Study dates
Sep 2009to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Sorlandet Hospital

    Kristiansand, Vest Agder, 4604

Other trials in Norway

About this study

Official title: Fit For Delivery: A Study of the Effect of Exercise Intervention 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.

Read the 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.
Being tested
Nutritional counseling + exercise groups
Keywords
Pregnancy, Preventive health care, Fitness, Nutrition, Obesity, Diabetes, Weight gain
Medical subject headings
Obesity, Diabetes Mellitus, Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional counseling + exercise groupsBehavioural

    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.

Study groups in NCT01001689
Study groupRoleWhat they receive
Nutritional counseling + exercise groupsExperimentalWomen 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.
Receives: Behavioral: Nutritional counseling + exercise groups
controlNo interventionWomen in this arm of the study will receive routine pregnancy care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal weight gain in pregnancy

    weight gain in kg

    Measured: Measured at the time of delivery

  2. Weight of the newborn

    weight in grams at delivery

    Measured: Measured at the time of delivery

  3. Maternal fasting serum glucose level

    serum glucose

    Measured: Measured at gestational week 30

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

    number of participants delivered by operative vaginal or cesarean section

    Measured: Assessed following delivery

  5. Maternal body composition

    Measured using bioimpedance scale

    Measured: Measured at 36 weeks of gestation

Secondary outcomes (5)

  1. Maternal weight retention

    weight change in kg from pre-pregnancy weight

    Measured: 12 months after delivery

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

    insulin, leptin

    Measured: Mother measured at gestational week 30, baby measured at delivery

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

    results of glucose challege test

    Measured: Assessed at gestational week 30

  4. Incidence of delivery complications

    incidence of third and fourth degree tearing, hemmorhage

    Measured: Assessed following delivery

  5. 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

    Measured: Assessed following delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionAug 2013
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01001689
Sponsor's protocol ID
811363
Acronym
FFF
Status last verified
Dec 2018
First submitted
26 Oct 2009
Last updated
5 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26768233

  • 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.

    PubMed 26786294

  • 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.

    PubMed 29739447

  • 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.

    PubMed 29724165

  • 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.

    PubMed 28577545

  • 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.

    PubMed 28376732

  • 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.

    PubMed 23406306

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional counseling + exercise groups in people with Pregnancy and Obesity, run by Sorlandet Hospital HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal weight gain in pregnancy (time frame: Measured at the time of delivery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01001689, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.

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