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

Sorlandet Hospital HF

Status: Completed

Conditions: Diabetes; Obesity; Pregnancy

Treatments: Behavioral: Nutritional counseling + exercise groups

Study type: Interventional

Funder types: Other

Identifiers

NCT01001689

811363

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 606 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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606 participants in 2 patient groups

Nutritional counseling + exercise groups

Experimental group

Description:

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.

Treatment:

Behavioral: Nutritional counseling + exercise groups

control

No Intervention group

Description:

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