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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Region Örebro County.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00451425
First Posted: March 23, 2007
Last Update Posted: May 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Region Örebro County
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.

Resource links provided by NLM:


Further study details as provided by Region Örebro County:

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 ]

Secondary Outcome Measures:
  • Weight retention(kg) up until one year after delivery is compared between study groups. [ Time Frame: one year after delivery ]
  • Number of fetal and maternal complications in pregnancy is compared between study groups [ Time Frame: 9 months ]
  • Number of fetal and maternal complications during delivery is compared between study groups [ Time Frame: 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Region Örebro County
Investigators
Study Chair: Kerstin Nilsson, MD. MD Region Örebro County
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Modrahalsovard Orebro lan, Orebro lans landsting
ClinicalTrials.gov Identifier: NCT00451425     History of Changes
Other Study ID Numbers: Dnr 2007/031
First Submitted: March 21, 2007
First Posted: March 23, 2007
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by Region Örebro County:
pregnancy
weight gain
obesity
macrosomia

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes