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

Weight Gain Clinical Trial

— VIGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00451425
• Other study ID #: Dnr 2007/031
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2007
• Last updated: May 28, 2009
• Start date: May 2007
• Est. completion date: October 2010

Study information

• Verified date: May 2009
• Source: University Hospital Orebro
• Contact: AnnKristin M Ronnberg, MD
• Phone: +46-19-602 6912
• Email: annkristin.roennberg[@]orebroll.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Weight Gain

Intervention

Behavioral:
• motivational intervention in pregnancy
Motivational program including individualized counseling on diet and physical activity

Locations

Country	Name	City	State
Sweden	Modrahalsovarden Orebro lan	Orebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups.		9 months	No
Secondary	Weight retention(kg) up until one year after delivery is compared between study groups.		one year after delivery	No
Secondary	Number of fetal and maternal complications in pregnancy is compared between study groups		9 months	No
Secondary	Number of fetal and maternal complications during delivery is compared between study groups		during delivery	No
Secondary	Child birth weight and weight development of the child up to one year of age is compared between study groups.		one year	No