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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

"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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)

NCT06734910

Pregnancy Related Weight Gain

RECRUITING NA

Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

NCT02564250

Pregnancy Obesity

UNKNOWN

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus

NCT05798494

Overweight and Obesity Weight Loss Pregnancy Related +2 more

RECRUITING NA

Pregnant Women Doing Resistance Exercise Training

NCT04780087

Pregnancy Related

COMPLETED

Healthy Living in Pregnancy

NCT01958307

Lifestyle Weight Gain Pregnancy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Obesity Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Nutritional counseling + exercise groups

Intervention Type 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.

control

Women in this arm of the study will receive routine pregnancy care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No