Weight Management for Improved Pregnancy Outcomes (Healthy Moms)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Obesity; Pregnancy	Behavioral: Weight Management; Other: Usual Care	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	118 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Weight Management for Improved Pregnancy Outcomes
Study Start Date :	October 2009
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	March 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. Pregnancy Weight Change [ Time Frame: baseline to 34 weeks gestation ]
2. 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.

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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 Posted:	July 31, 2009
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