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

NCT01001689 | Completed DMC

• 1 other identifier: 811363
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

Brief Summary

"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.

Conditions

Pregnancy; Obesity; Diabetes

Keywords

Pregnancy; Preventive health care; Fitness; Nutrition; Obesity; Diabetes; Weight gain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Maternal weight retention

  12 months after delivery

• Measurement of serum levels of hormones which regulate serum glucose levels, in both the pregnant woman and her newborn baby.

  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

  Assessed at gestational week 30

• Incidence of delivery complications

  Assessed following delivery

• Proportion of newborns with birth weight over the 90th percentile for gestational age

  Assessed following delivery

Study Arms (2)

Nutritional counseling + exercise groups

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

Nutritional counseling + exercise groups BEHAVIORAL

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.

Nutritional counseling + exercise groups

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Expecting first child
• Gestational weeks 12-20
• Residence in one of the following towns: Kristiansand, Søgne, Sogndalen, Vennesla, Lillesand, Mandal

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Hospital

Kristiansand, Vest Agder, 4604, Norway

Location

Related Publications (7)

• Sagedal LR, Overby NC, Bere E, Torstveit MK, Lohne-Seiler H, Smastuen M, Hillesund ER, Henriksen T, Vistad I. Lifestyle intervention to limit gestational weight gain: the Norwegian Fit for Delivery randomised controlled trial. BJOG. 2017 Jan;124(1):97-109. doi: 10.1111/1471-0528.13862. Epub 2016 Jan 14.

  PMID: 26768233 BACKGROUND

• Sagedal LR, Sanda B, Overby NC, Bere E, Torstveit MK, Lohne-Seiler H, Hillesund ER, Pripp AH, Henriksen T, Vistad I. The effect of prenatal lifestyle intervention on weight retention 12 months postpartum: results of the Norwegian Fit for Delivery randomised controlled trial. BJOG. 2017 Jan;124(1):111-121. doi: 10.1111/1471-0528.13863. Epub 2016 Jan 20.

  PMID: 26786294 BACKGROUND

• Hillesund ER, Seland S, Bere E, Sagedal LR, Torstveit MK, Lohne-Seiler H, Vistad I, Overby NC. Preeclampsia and gestational weight gain in the Norwegian Fit for Delivery trial. BMC Res Notes. 2018 May 8;11(1):282. doi: 10.1186/s13104-018-3396-4.

  PMID: 29739447 DERIVED

• Haakstad LAH, Vistad I, Sagedal LR, Lohne-Seiler H, Torstveit MK. How does a lifestyle intervention during pregnancy influence perceived barriers to leisure-time physical activity? The Norwegian fit for delivery study, a randomized controlled trial. BMC Pregnancy Childbirth. 2018 May 3;18(1):127. doi: 10.1186/s12884-018-1771-8.

  PMID: 29724165 DERIVED

• Sagedal LR, Vistad I, Overby NC, Bere E, Torstveit MK, Lohne-Seiler H, Hillesund ER, Pripp A, Henriksen T. The effect of a prenatal lifestyle intervention on glucose metabolism: results of the Norwegian Fit for Delivery randomized controlled trial. BMC Pregnancy Childbirth. 2017 Jun 2;17(1):167. doi: 10.1186/s12884-017-1340-6.

  PMID: 28577545 DERIVED

• Skreden M, Bere E, Sagedal LR, Vistad I, Overby NC. Changes in fruit and vegetable consumption habits from pre-pregnancy to early pregnancy among Norwegian women. BMC Pregnancy Childbirth. 2017 Apr 4;17(1):107. doi: 10.1186/s12884-017-1291-y.

  PMID: 28376732 DERIVED

• Sagedal LR, Overby NC, Lohne-Seiler H, Bere E, Torstveit MK, Henriksen T, Vistad I. Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial. BMC Public Health. 2013 Feb 13;13:132. doi: 10.1186/1471-2458-13-132.

  PMID: 23406306 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Weight Gain

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ingvild Vistad, MD, PhD

  Sorland Hospital HF

  PRINCIPAL INVESTIGATOR

• Tore Henriksen, MD, PhD

  University Hospital of Oslo, Rikshospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2014
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

NO (1)