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Weight Management for Improved Pregnancy Outcomes (Healthy Moms)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00950235

First Posted: July 31, 2009

Last Update Posted: July 9, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Kaiser Permanente

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 Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Weight Management for Improved Pregnancy Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Body Weight

Genetic and Rare Diseases Information Center resources: Fetal Macrosomia

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

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 Outcome Measures:

Pregnancy Weight Change [ Time Frame: baseline to 34 weeks gestation ]
Large for Gestational Age (LGA) [ Time Frame: At birth ]
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):

Vesco KK, Karanja N, King JC, Gillman MW, Leo MC, Perrin N, McEvoy CT, Eckhardt CL, Smith KS, Stevens VJ. Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial. Obesity (Silver Spring). 2014 Sep;22(9):1989-96. doi: 10.1002/oby.20831.

Vesco KK, Karanja N, King JC, Gillman MW, Perrin N, McEvoy C, Eckhardt C, Smith KS, Stevens VJ. Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale. Contemp Clin Trials. 2012 Jul;33(4):777-85. doi: 10.1016/j.cct.2012.03.006. Epub 2012 Mar 20.


Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00950235 History of Changes
Other Study ID Numbers:	1R01HD058061-01A1 ( U.S. NIH Grant/Contract ) 1R01HD058061 ( U.S. NIH Grant/Contract )
First Submitted:	July 29, 2009
First Posted:	July 31, 2009
Results First Submitted:	May 28, 2015
Results First Posted:	July 9, 2015
Last Update Posted:	July 9, 2015
Last Verified:	June 2015

Keywords provided by Kaiser Permanente:


obese pregnant large for gestational age large for gestational age baby

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