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Effect of Regular Exercise in Prevention of Excessive Weight Gain in Pregnancy

This study has been completed.
Sponsor:
Information provided by:
Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier:
NCT00617149
First received: February 4, 2008
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

Background:

Use of variable definitions of exercise and disparate results, emphasize the need of proper randomized controlled trials examining the relationship between physical activity and weight development during pregnancy. So far, only few intervention studies aiming at weight management during pregnancy have been performed (Gray-Donald et al., 2000,Olson et al., 2004,Polley et al., 2002,Kinnunen et al., 2007). Moreover, most of these interventions have focused on how gestational weight gain may be altered through individual counselling combining diet and exercise habits, rather than supervised training. Search on PubMed revealed no randomized controlled trial where the main outcome was to investigate how the effect of supervised structured exercise may reduce the proportion of women gaining more weight than optimal. The aim of the present study is to assess whether a 12-week aerobic exercise program during pregnancy can prevent excessive gestational weight gain.

Method:

This is a single blind randomized controlled trial to evaluate the effects of a structured, supervised aerobic exercise program on weight gain stabilization in primiparous pregnant women. The aim is to include 100 women. Interested women eligible for the present study will be invited to a pre-test including interview and assessments at the university. The women are examined three times during the study period. The first visit is between 12 and 24 weeks of gestation, the second at week 36-38 and the last 8-12 week after delivery. The exercise program consists of supervised exercise for 60 minutes, performed at least 2 times per week, for 12-16 weeks. Compliance with the training protocol is controlled by the instructors and registrations in the womens personal training diary


Condition Intervention Phase
Pregnancy
Excessive Weight Gain
 Behavioral: Supervised exercise for the prevention high weight gain
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Regular Exercise in Prevention of Excessive Weight Gain in Pregnancy. A Single Blind Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian School of Sport Sciences:

Primary Outcome Measures:
  • Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations. [ Time Frame: week 36-38 of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes are pregnancy complications, relationship between oxygen consumption, heart rate and blood lactate concentration at submaximal work loads, infant birth weight, length of labour and complications during delivery. [ Time Frame: week 36-38 of gestation ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Supervised exercise for the prevention high weight gain
    Each session starts with ca 5 minutes warm up, followed by 30 minutes of aerobic activity, including cool down. This is followed by 15 minutes of strength training of the upper and lower limbs, and special focus on the deep abdominal stabilization muscles. The last 5 minutes contains stretching, relaxation and body awareness exercises. The exercise-program follows the ACOG exercise prescription, and all aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate), measured by ratings of perceived exertion at 11-14 (somewhat hard) on the 6-20 Borg's rating scale. Control-participants are neither encouraged nor discouraged from exercising.
    Other Name: exercise, excessive weight gain, pregnant women
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past six months are eligible for the trial.
  • Other inclusion criteria are ability to read, write and speak Norwegian, and to be within their first 24 weeks of pregnancy.

Exclusion Criteria:

  • Severe heart disease
  • Pregnancy induced hypertension
  • History of more than two miscarriages
  • Persistent bleeding after week 12 of gestation
  • Poorly controlled thyroid disease
  • Poorly controlled pre-eclampsia and/or other diseases that could interfere with participation (Artal and O'Toole, 2003)
  • In addition, all women who live to far from the university to be able to attend weekly training groups will be ineligible
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617149

Locations
Norway
Norwegian School of Sport Science
Oslo, Norway, 0806
Sponsors and Collaborators
Norwegian School of Sport Sciences
Investigators
Principal Investigator: Lene Haakstad, PhD student Norwegian School of Sport Science
  More Information

No publications provided by Norwegian School of Sport Sciences

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

Responsible Party: Lene AH Haakstad, Msci, Ph.D student, Exercise scientist, Norwegian School of Sport Sciences, Department of Sport Medicine
ClinicalTrials.gov Identifier: NCT00617149     History of Changes
Other Study ID Numbers: S-05208 (REK), 17804/2/KH (NSD)
Study First Received: February 4, 2008
Last Updated: September 17, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian School of Sport Sciences:
exercise,
excessive weight gain during pregnancy

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013