- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451425
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain (VIGA)
May 28, 2009 updated by: Region Örebro County
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.
Excessive weight gain during pregnancy is associated with complications during delivery primarily due to macrosomia (large babies) but also with high levels of weight retention post pregnancy and thereby increased risk of future weight related health problems.
The primary aim of this study is to evaluate the efficacy of an intervention consisting of; recurrent Motivational Interviewing (MI), prescription of physical activity and extended information on recommended weight gain during pregnancy in regards to preventing excessive gestational weight gain.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
430
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AnnKristin M Ronnberg, MD
- Phone Number: +46-19-602 6912
- Email: annkristin.roennberg@orebroll.se
Study Contact Backup
- Name: Kerstin Nilsson, MD
- Email: kerstin.nilsson@orebroll.se
Study Locations
-
-
-
Orebro, Sweden
- Recruiting
- Modrahalsovarden Orebro lan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- >18 years,
- Adequate language skills (swedish),
- BMI>19.9,
- Pregnancy estimated <16 weeks (LMP),
- Planned for basic pregnancy surveillance (healthy mother).
Exclusion Criteria:
- History of eating disorder,
- History of having a growth restricted child.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
standard maternity care
|
Motivational program including individualized counseling on diet and physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight retention(kg) up until one year after delivery is compared between study groups.
Time Frame: one year after delivery
|
one year after delivery
|
Number of fetal and maternal complications in pregnancy is compared between study groups
Time Frame: 9 months
|
9 months
|
Number of fetal and maternal complications during delivery is compared between study groups
Time Frame: during delivery
|
during delivery
|
Child birth weight and weight development of the child up to one year of age is compared between study groups.
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kerstin Nilsson, MD. MD, Region Örebro County
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
October 1, 2010
Study Registration Dates
First Submitted
March 21, 2007
First Submitted That Met QC Criteria
March 22, 2007
First Posted (Estimate)
March 23, 2007
Study Record Updates
Last Update Posted (Estimate)
May 29, 2009
Last Update Submitted That Met QC Criteria
May 28, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2007/031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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