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

December 3, 2018 updated by: Sorlandet Hospital HF

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
606

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Vest Agder
      • Kristiansand, Vest Agder, Norway, 4604
        • Sorlandet hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nutritional counseling + exercise groups
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.
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.
No Intervention: control
Women in this arm of the study will receive routine pregnancy care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maternal weight gain in pregnancy
Time Frame: Measured at the time of delivery
weight gain in kg
Measured at the time of delivery
Weight of the newborn
Time Frame: Measured at the time of delivery
weight in grams at delivery
Measured at the time of delivery
Maternal fasting serum glucose level
Time Frame: Measured at gestational week 30
serum glucose
Measured at gestational week 30
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
Assessed following delivery
Maternal body composition
Time Frame: Measured at 36 weeks of gestation
Measured using bioimpedance scale
Measured at 36 weeks of gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal weight retention
Time Frame: 12 months after delivery
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.
Time Frame: Mother measured at gestational week 30, baby measured at delivery
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
Time Frame: Assessed at gestational week 30
results of glucose challege test
Assessed at gestational week 30
Incidence of delivery complications
Time Frame: Assessed following delivery
incidence of third and fourth degree tearing, hemmorhage
Assessed following delivery
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
Assessed following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sorlandet Hospital HF

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ingvild Vistad, MD, PhD, Sorland Hospital HF
  • Study Chair: Tore Henriksen, MD, PhD, University Hospital of Oslo, Rikshospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 811363

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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