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Clinical Trials/NCT00950235
NCT00950235
Completed
N/A

Weight Management for Improved Pregnancy Outcomes

Kaiser Permanente1 site in 1 country118 target enrollmentOctober 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Kaiser Permanente
Enrollment
118
Locations
1
Primary Endpoint
Maternal Weight Change
Status
Completed
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
March 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Maternal Weight Change

Time Frame: 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 Outcomes

  • Large for Gestational Age (LGA)(At birth)
  • Pregnancy Weight Change(baseline to 34 weeks gestation)

Study Sites (1)

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