Back to resultsWeight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain (VIGA)
Primary Purpose
Weight Gain
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
motivational intervention in pregnancy
Sponsored by
About this trial
This is an interventional prevention trial for Weight Gain focused on measuring pregnancy, weight gain, obesity, macrosomia
Eligibility Criteria
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.
Sites / Locations
- Modrahalsovarden Orebro lanRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
control
Arm Description
standard maternity care
Outcomes
Primary Outcome Measures
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
Secondary Outcome Measures
Weight retention(kg) up until one year after delivery is compared between study groups.
Number of fetal and maternal complications in pregnancy is compared between study groups
Number of fetal and maternal complications during delivery is compared between study groups
Child birth weight and weight development of the child up to one year of age is compared between study groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00451425
Brief Title
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain
Acronym
VIGA
Official Title
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
October 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Region Örebro County
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
pregnancy, weight gain, obesity, macrosomia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
standard maternity care
Intervention Type
Behavioral
Intervention Name(s)
motivational intervention in pregnancy
Intervention Description
Motivational program including individualized counseling on diet and physical activity
Primary Outcome Measure Information:
Title
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Weight retention(kg) up until one year after delivery is compared between study groups.
Time Frame
one year after delivery
Title
Number of fetal and maternal complications in pregnancy is compared between study groups
Time Frame
9 months
Title
Number of fetal and maternal complications during delivery is compared between study groups
Time Frame
during delivery
Title
Child birth weight and weight development of the child up to one year of age is compared between study groups.
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AnnKristin M Ronnberg, MD
Phone
+46-19-602 6912
Email
annkristin.roennberg@orebroll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kerstin Nilsson, MD
Email
kerstin.nilsson@orebroll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerstin Nilsson, MD. MD
Organizational Affiliation
Region Örebro County
Official's Role
Study Chair
Facility Information:
Facility Name
Modrahalsovarden Orebro lan
City
Orebro
Country
Sweden
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
25367823
Citation
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.
Results Reference
derived
Learn more about this trial
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain
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