Sorlandet Hospital
Kristiansand, Vest Agder, 4604, Norway
NCT Number: NCT01001689
"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.
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Kristiansand, Vest Agder, 4604, Norway
"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:
The investigators' hypothesis is that an intervention in the form of nutritional information and exercise groups will:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Measured at the time of delivery
weight gain in kg
Time frame: Measured at the time of delivery
weight in grams at delivery
Time frame: Measured at gestational week 30
serum glucose
Time frame: Assessed following delivery
number of participants delivered by operative vaginal or cesarean section
Time frame: Measured at 36 weeks of gestation
Measured using bioimpedance scale
Time frame: 12 months after delivery
weight change in kg from pre-pregnancy weight
Time frame: Mother measured at gestational week 30, baby measured at delivery
insulin, leptin
Time frame: Assessed at gestational week 30
results of glucose challege test
Time frame: Assessed following delivery
incidence of third and fourth degree tearing, hemmorhage
Time frame: Assessed following delivery
weight at gestation, adjusted for population characteristics stratified by sex and gestational age
Sorlandet Hospital HF
Other Gov
Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.
Acronym: FFF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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