Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain (VIGA)

May 28, 2009 updated by: Region Örebro County

Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Orebro, Sweden
        • Recruiting
        • Modrahalsovarden Orebro lan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
standard maternity care
Motivational program including individualized counseling on diet and physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.
Time Frame: 9 months
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kerstin Nilsson, MD. MD, Region Örebro County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

March 21, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (Estimate)

March 23, 2007

Study Record Updates

Last Update Posted (Estimate)

May 29, 2009

Last Update Submitted That Met QC Criteria

May 28, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • Dnr 2007/031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Gain

Clinical Trials on motivational intervention in pregnancy

3
Subscribe