Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Norwegian School of Sport Sciences |
---|---|
Information provided by: | Norwegian School of Sport Sciences |
ClinicalTrials.gov Identifier: | NCT00617149 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Regular Exercise in Prevention of Excessive Weight Gain in Pregnancy. A Single Blind Randomized Controlled Trial |
Estimated Enrollment: | 100 |
Study Start Date: | November 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Norwegian School of Sport Science | |
OSLO, Norway, 0806 |
Principal Investigator: | Lene Haakstad, PhD student | Norwegian School of Sport Science |
Responsible Party: | Norwegian School of Sport Sciences, Department of Sport Medicine ( Lene AH Haakstad, Msci, Ph.D student, Exercise scientist ) |
Study ID Numbers: | S-05208 (REK), 17804/2/KH (NSD) |
Study First Received: | February 4, 2008 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00617149 History of Changes |
Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services |
exercise, excessive weight gain during pregnancy |
Body Weight Signs and Symptoms Body Weight Changes Weight Gain |
Body Weight Signs and Symptoms Body Weight Changes Weight Gain |