Exercise Training in Pregnancy for Obese Mothers

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborators:
Harvard Medical School
Norwegian School of Sport Sciences
Karolinska Institutet
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01243554
First received: September 6, 2010
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia, nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures. There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women) and a recent study has shown that fetuses of obese mothers develop insulin resistance in uterus.

Main aims of this study are to assess if regular exercise in pregnancy among obese women can prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn; impaired vascular function in mother; insulin resistance/sensitivity; body composition in mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor


Condition Intervention
Pregnancy
Obesity
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exercise Training in Pregnancy. Good for the Mother - Good for the Child?

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Weight gain during pregnancy [ Time Frame: From 14 weeks pregnancy to delivery ] [ Designated as safety issue: No ]
    Measured in kg


Secondary Outcome Measures:
  • Fasting glucose [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Blood samples to determine the fasting glucose after an overnight fast (>10 hours)

  • Glucose tolerance [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    2 hour 75 mg per-oral glucose tolerance test. Gestational diabetes is diagnosed as fasting glucose = or > 6.9 mmol/L or 2h concentration = or > 7.8 mmol/L.

  • Insulin resistance [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Homeostasis model assessment (HOMA-IR)

  • Body composition [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Skinfold measurements, done by an experienced investigator using Harpenden kaliper. At the 3 months postpartum testing, also dual energy x-ray absorptiometry (DEXA scan) will be used.

  • Blood markers for cardiovascular disease [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses.

  • Lumbopelvic pain [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.

  • Urin- and fecal incontinence [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Pelvic floor muscle function will be assessed by clinical assessment and by 2D and 3D ultrasound. The prevalence and severity of urin- and fecal incontinence will also be assessed by a validated questionnaire

  • Quality of life [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Validated questionnaire

  • Sleep [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Epworth sleepiness scale

  • Physical activity [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires

  • Diet [ Time Frame: From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum ] [ Designated as safety issue: No ]
    Validated questionnaire: Norkost

  • Offspring birth weight, length and head circumference [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    As recorded by the hospital

  • Delivery complications [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Vaginal or caesarean delivery, and recorded complications during the delviery

  • Markers of inflammation and metabolism in cord blood [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)


Estimated Enrollment: 150
Study Start Date: September 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training
Supervised exercise training at the hospital during pregnancy: the women will attend at least 2 weekly sessions consisting of aerobic exercise (walking on treadmills), strength training (for upper body, back, abdomen and legs) as well as pelvic floor muscle exercises. Each session is 60 minutes and lead by a physiotherapist or experienced exercise physiologist. The women will also go through motivational interviewing sessions throughout the intervention period and are encouraged to do home exercise training in addition to the exercise at the hospital
Behavioral: Exercise
Exercise training at the hospital
Other Name: Training
No Intervention: Control
Usual care as provided by the health services in Norway. The investigators will not advice the women to be inactive

Detailed Description:

Women with a self-reported pre-pregnancy BMI of 28 or more will be eligible for our study. Woman are eligible if they are 18 years or older, with a singleton live fetus at an early (week 12-14) ultrasound scan. Exclusion criteria are pregnancy complications with high risk for preterm labour or diseases that could interfere with participation.

Primary outcome measure is weight increase based on weight measured at 14 weeks and immediately before labour. Assessments are done at baseline at 14 (12-18) weeks of pregnancy, and again in week 38, as well as 3 months postpartum. Some measurements are also done at other points in time. The maternal secondary outcome measurements include fasting glucose, glucose tolerance assessed by 2-h, 75 mg per-oral glucose tolerance test, insulin resistance assessed by HOMA-IR, weight, height, body composition estimated by skinfold measurements in pregnancy and by dual energy x-ray absorptiometry postpartum, blood markers, lumbopelvic pain, urin- and fecal incontinence, quality of life, psychological wellbeing, depression, and diet.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-pregnancy body mass index of 28 or more
  • 18 years or more
  • singleton live fetus at the routine ultrasound scan

Exclusion Criteria:

  • high risk for preterm labor or diseases that could interfere with participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243554

Contacts
Contact: Trine T Moholdt, PhD + 47 97098594 trine.moholdt@ntnu.no
Contact: Siv Mørkved, PhD + 47 971 46 490 siv.morkved@ntnu.no

Locations
Norway
Norwegian University of Science and Technology Recruiting
Trondheim, Norway, 7489
Principal Investigator: Trine Moholdt, PhD         
Sub-Investigator: Arnt Erik Tjønna, PhD         
Sub-Investigator: Kelly McCammon         
Sub-Investigator: Siv Mørkved, PhD         
Sub-Investigator: Charlotte B Ingul, PhD         
Sub-Investigator: Kjell Å Salvesen, PhD         
Sub-Investigator: Ingrid Volløyhaug, MD         
Sponsors and Collaborators
Norwegian University of Science and Technology
Harvard Medical School
Norwegian School of Sport Sciences
Karolinska Institutet
St. Olavs Hospital
Investigators
Principal Investigator: Trine T Moholdt, PhD Norwegian University of Science and Technology
  More Information

No publications provided by Norwegian University of Science and Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01243554     History of Changes
Other Study ID Numbers: ETiP-Ob
Study First Received: September 6, 2010
Last Updated: April 16, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian University of Science and Technology:
Exercise training
Pregnancy
Obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014