Weight Management for Improved Pregnancy Outcomes

Not Applicable

Completed

• Conditions: Pregnancy; Obesity
• Interventions: Other: Usual Care; Behavioral: Weight Management

• Registration Number: NCT00950235
• Lead Sponsor: Kaiser Permanente

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Study Start: 2009-10
• Primary Completion: 2012-03
• Study Completion: 2013-03
• Results First Submitted: 2015-05-28
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-11
• Last Update Submitted: 2015-06-11
• Results First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group
Weight Management Counseling	Weight Management	In-person and group session counseling

Primary Outcome Measures

Name	Time	Method
Maternal Weight Change	baseline to 2 weeks post partum	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.

Secondary Outcome Measures

Name	Time	Method
Large for Gestational Age (LGA)	At birth	Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.
Pregnancy Weight Change	baseline to 34 weeks gestation

Trial Locations

Locations (1)

Kaiser Permanente Center for Health Research; 🇺🇸 Portland, Oregon, United States