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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy, Obesity, Diabetes

Intervention / Treatment
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* Behavioral: Nutritional counseling + exercise groups


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional counseling + exercise groups<br>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<br>* 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.<br>|
| No Intervention: control<br>Women in this arm of the study will receive routine pregnancy care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight gain in pregnancy | weight gain in kg | Measured at the time of delivery | 
| Weight of the newborn | weight in grams at delivery | Measured at the time of delivery | 
| Maternal fasting serum glucose level | serum glucose | Measured at gestational week 30 | 
| Incidence of operative delivery, both cesarean section and operative vaginal delivery | number of participants delivered by operative vaginal or cesarean section | Assessed following delivery | 
| Maternal body composition | Measured using bioimpedance scale | Measured at 36 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight retention | 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. | 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 | results of glucose challege test | Assessed at gestational week 30 | 
| Incidence of delivery complications | incidence of third and fourth degree tearing, hemmorhage | Assessed following delivery | 
| 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 | Assessed following delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Preventive health care, Fitness, Nutrition, Obesity, Diabetes, Weight gain