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Weight Management for Improved Pregnancy Outcomes (Healthy Moms)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00950235
First received: July 29, 2009
Last updated: June 11, 2015
Last verified: June 2015
  Purpose
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

Condition Intervention
Obesity
Pregnancy
Behavioral: Weight Management
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Weight Management for Improved Pregnancy Outcomes

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Maternal Weight Change [ Time Frame: baseline to 2 weeks post partum ] [ Designated as safety issue: No ]
    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:
  • Pregnancy Weight Change [ Time Frame: baseline to 34 weeks gestation ] [ Designated as safety issue: No ]
  • Large for Gestational Age (LGA) [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.


Enrollment: 118
Study Start Date: October 2009
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Usual Care
Standard nutrition counseling from Health Plan
Experimental: Weight Management Counseling
In-person and group session counseling
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950235

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Victor J Stevens, PhD Kaiser Permanente
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00950235     History of Changes
Other Study ID Numbers: 1R01HD058061-01A1  1R01HD058061 
Study First Received: July 29, 2009
Results First Received: May 28, 2015
Last Updated: June 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
obese
pregnant
large for gestational age
large for gestational age baby

ClinicalTrials.gov processed this record on September 26, 2016