Fit For Delivery: A Study of the Effect of Exercise Sessions and Nutritional Counselling on Pregnancy Outcome (FFF)
|ClinicalTrials.gov Identifier: NCT01001689|
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : January 18, 2018
"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. We intend to study 600 women who are expecting their first child, and include them in our 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:
- 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.
Our 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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Obesity Diabetes||Behavioral: Nutritional counseling and twice weekly exercise groups||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||606 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||September 2014|
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 and twice weekly 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.
- Maternal weight gain in pregnancy [ Time Frame: Measured at the time of delivery ]
- Weight of the newborn [ Time Frame: Measured at the time of delivery ]
- Maternal fasting serum glucose level [ Time Frame: Measured at gestational week 30 ]
- Incidence of operative delivery, both cesarean section and operative vaginal delivery [ Time Frame: Assessed following delivery ]
- Maternal body composition [ Time Frame: Measured at 36 weeks of gestation ]Measured using bioimpedance scale
- Maternal weight retention [ Time Frame: 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 ]
- Incidence of women with serum glucose levels >7.8 mmol/l after 2 hour glucose challenge test [ Time Frame: Assessed at gestational week 30 ]
- Incidence of delivery complications [ Time Frame: Assessed following delivery ]
- Proportion of newborns with birth weight over the 90th percentile for gestational age [ Time Frame: Assessed following delivery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001689
|Kristiansand, Vest Agder, Norway, 4604|
|Principal Investigator:||Ingvild Vistad, MD, PhD||Sorland Hospital HF|
|Study Chair:||Tore Henriksen, MD, PhD||University Hospital of Oslo, Rikshospital|