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
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT00451425
First received: March 21, 2007
Last updated: May 28, 2009
Last verified: May 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014