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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01001689
First received: October 26, 2009
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

"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:

  • 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.

Our 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.

Condition Intervention
Pregnancy
Obesity
Diabetes
 Behavioral: Nutritional counseling and twice weekly exercise groups

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Fit For Delivery: A Study of the Effect of Exercise Intervention and Nutritional Counselling on Pregnancy Outcome.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Maternal weight gain in pregnancy [ Time Frame: Measured at the time of delivery ] [ Designated as safety issue: No ]
  • Weight of the newborn [ Time Frame: Measured at the time of delivery ] [ Designated as safety issue: No ]
  • Maternal fasting serum glucose level [ Time Frame: Measured at gestational week 30 ] [ Designated as safety issue: No ]
  • Incidence of operative delivery, both cesarean section and operative vaginal delivery [ Time Frame: Assessed following delivery ] [ Designated as safety issue: No ]
  • Maternal body composition [ Time Frame: Measured at 36 weeks of gestation ] [ Designated as safety issue: No ]
    Measured using bioimpedance scale


Secondary Outcome Measures:
  • Maternal weight retention [ Time Frame: 12 months after delivery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of women with serum glucose levels >7.8 mmol/l after 2 hour glucose challenge test [ Time Frame: Assessed at gestational week 30 ] [ Designated as safety issue: No ]
  • Incidence of delivery complications [ Time Frame: Assessed following delivery ] [ Designated as safety issue: No ]
  • Proportion of newborns with birth weight over the 90th percentile for gestational age [ Time Frame: Assessed following delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001689

Locations
Norway
Sorlandet Hospital
Kristiansand, Vest Agder, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Ingvild Vistad, MD, PhD Sorland Hospital HF
Study Chair: Tore Henriksen, MD, PhD University Hospital of Oslo, Rikshospital
  More Information

No publications provided by Sorlandet Hospital HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01001689     History of Changes
Other Study ID Numbers: 811363
Study First Received: October 26, 2009
Last Updated: May 21, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Institute of Public Health
Norway: Norwegian Social Science Data Services

Keywords provided by Sorlandet Hospital HF:
Pregnancy
Preventive health care
Fitness
Nutrition
 Obesity
Diabetes
Weight gain

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013