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

History of Changes

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:

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 ] [ 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):

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 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

To Top