Weight Management for Improved Pregnancy Outcomes

Obesity Clinical Trial

— Healthy Moms  

Official title:

Weight Management for Improved Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950235
• Other study ID #: 1R01HD058061-01A1
• Secondary ID: 1R01HD058061
• Status: Completed
• Phase: N/A
• First received: July 29, 2009
• Last updated: June 11, 2015
• Start date: October 2009
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI 30 or more

• Less than 20 weeks gestation

• member of Kaiser Permanente Northwest (NW)

• receive pre-natal care at Kaiser Permanente NW

• speaks English

Exclusion Criteria:

• no current treatment for cancer

• no bariatric surgery

• no current renal disease

• no multiple birth anticipated

• no hyperemesis requiring hospitalization

• no diabetes (type 1 or 2)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Pregnancy

Intervention

Behavioral:
• Weight Management
Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy

Other:
• Usual Care
Standard nutrition counseling from Health Plan

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Weight Change	We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.	baseline to 2 weeks post partum	No
Secondary	Pregnancy Weight Change		baseline to 34 weeks gestation	No
Secondary	Large for Gestational Age (LGA)	Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.	At birth	No