Weight Management for Improved Pregnancy Outcomes - Full Text View

Sponsor:	Kaiser Permanente
Collaborator:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00950235

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	Phase
Obesity Pregnancy	Behavioral: Weight Management Other: Usual Care	Phase II Phase III

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: Obesity

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

Mother weight gain [ Time Frame: baseline to 34 weeks gestation ] [ Designated as safety issue: No ]
Mother weight gain [ Time Frame: baseline to 2 weeks post partum ] [ Designated as safety issue: No ]
Large for Gestational Age baby [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

acceptability of weight management program [ Time Frame: post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2009
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	February 2013 (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
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI 30 or more
12-16 weeks gestation
member of Kaiser Permanente NW
receive pre-natal care at Kaiser Permanete 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

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

Contacts

Contact: Sabina Smith	503 335 6782	sabina.smith@kpchr.org
Contact: Kim Vesco, MD	503 335 2400	kimberly.vesco@kpchr.org

Locations

United States, Oregon
Kaiser Permanente Center for Health Research	Recruiting
Portland, Oregon, United States, 97227
Principal Investigator: Victor J Stevens, PhD
Sub-Investigator: Kim Vesco, MD
Sub-Investigator: Njeri Karanja, PhD
Sub-Investigator: Nancy Perrin, PhD
Sub-Investigator: Cynthia McEvoy, MD

Sponsors and Collaborators

Kaiser Permanente

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

More Information

No publications provided

Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00950235 History of Changes
Other Study ID Numbers:	1R01HD058061-01A1
Study First Received:	July 29, 2009
Last Updated:	November 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Kaiser Permanente:

obese
pregnant
large for gestational age
large for gestational age baby

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012