Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain
VIGA
1 other identifier
interventional
430
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2007
CompletedFirst Posted
Study publicly available on registry
March 23, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMay 29, 2009
May 1, 2009
2.6 years
March 21, 2007
May 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
9 months
Secondary Outcomes (4)
Weight retention(kg) up until one year after delivery is compared between study groups.
one year after delivery
Number of fetal and maternal complications in pregnancy is compared between study groups
9 months
Number of fetal and maternal complications during delivery is compared between study groups
during delivery
Child birth weight and weight development of the child up to one year of age is compared between study groups.
one year
Study Arms (1)
control
NO INTERVENTIONstandard maternity care
Interventions
Motivational program including individualized counseling on diet and physical activity
Eligibility Criteria
You may qualify if:
- \>18 years,
- Adequate language skills (swedish),
- BMI\>19.9,
- Pregnancy estimated \<16 weeks (LMP),
- Planned for basic pregnancy surveillance (healthy mother).
You may not qualify if:
- History of eating disorder,
- History of having a growth restricted child.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Modrahalsovarden Orebro lan
Örebro, Sweden
Related Publications (1)
Ronnberg AK, Ostlund I, Fadl H, Gottvall T, Nilsson K. Intervention during pregnancy to reduce excessive gestational weight gain-a randomised controlled trial. BJOG. 2015 Mar;122(4):537-44. doi: 10.1111/1471-0528.13131. Epub 2014 Nov 4.
PMID: 25367823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kerstin Nilsson, MD. MD
Region Örebro County
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 21, 2007
First Posted
March 23, 2007
Study Start
May 1, 2007
Primary Completion
December 1, 2009
Study Completion
October 1, 2010
Last Updated
May 29, 2009
Record last verified: 2009-05