Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain (VIGA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Hospital Orebro.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital Orebro
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00451425
First received: March 21, 2007
Last updated: May 28, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Weight Gain |
Behavioral: motivational intervention in pregnancy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain. |
Further study details as provided by University Hospital Orebro:
Primary Outcome Measures:
- The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Weight retention(kg) up until one year after delivery is compared between study groups. [ Time Frame: one year after delivery ] [ Designated as safety issue: No ]
- Number of fetal and maternal complications in pregnancy is compared between study groups [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Number of fetal and maternal complications during delivery is compared between study groups [ Time Frame: during delivery ] [ Designated as safety issue: No ]
- Child birth weight and weight development of the child up to one year of age is compared between study groups. [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 430 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control
standard maternity care
|
Behavioral: motivational intervention in pregnancy
Motivational program including individualized counseling on diet and physical activity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451425
Contacts
| Contact: AnnKristin M Ronnberg, MD | +46-19-602 6912 | annkristin.roennberg@orebroll.se |
| Contact: Kerstin Nilsson, MD | kerstin.nilsson@orebroll.se |
Locations
| Sweden | |
| Modrahalsovarden Orebro lan | Recruiting |
| Orebro, Sweden | |
Sponsors and Collaborators
University Hospital Orebro
Investigators
| Study Chair: | Kerstin Nilsson, MD. MD | University Hospital Orebro |
More Information
No publications provided
| Responsible Party: | Modrahalsovard Orebro lan, Orebro lans landsting |
| ClinicalTrials.gov Identifier: | NCT00451425 History of Changes |
| Other Study ID Numbers: | Dnr 2007/031 |
| Study First Received: | March 21, 2007 |
| Last Updated: | May 28, 2009 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University Hospital Orebro:
|
pregnancy weight gain obesity macrosomia |
Additional relevant MeSH terms:
|
Weight Gain Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013