Weightgain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weightgain - Full Text View

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

This study is not yet open for participant recruitment.

Verified by University Hospital Orebro, March 2007

First Received: March 21, 2007 Last Updated: March 22, 2007 History of Changes

Sponsored by:	University Hospital Orebro
Information provided by:	University Hospital Orebro
ClinicalTrials.gov Identifier:	NCT00451425

Purpose

Excessive weightgain 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 weightrelated healthproblems. 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 weightgain during pregnancy in regards to preventing excessive gestational weight gain.

Condition	Intervention
Weight Gain	Behavioral: MI, Phys. Activity prescription, Weightgain recommendation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:

The number of women with a weightgain during pregnancy within IOM´s recommendation is compared between studygroups.

Secondary Outcome Measures:

Weight retention(kg) up until one year after delivery is compared between studygroups.
Number of fetal and maternal complications in pregnancy is compared between studygroups
Number of fetal and maternal complications during delivery is compared between studygroups
Child birthweight and weight development of the child up to three years of age is compared between studygroups.

Estimated Enrollment:	430
Study Start Date:	May 2007

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
Orebro, Sweden

Sponsors and Collaborators

University Hospital Orebro

Investigators

Study Chair:

Kerstin Nilsson, MD. MD

University Hospital Orebro

More Information

No publications provided

Study ID Numbers:	Dnr 2007/031
Study First Received:	March 21, 2007
Last Updated:	March 22, 2007
ClinicalTrials.gov Identifier:	NCT00451425 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital Orebro:

pregnancy
weightgain
obesity
macrosomia

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Body Weight Changes
Weight Gain

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Body Weight Changes
Weight Gain

ClinicalTrials.gov processed this record on May 07, 2009