Weight Management for Improved Pregnancy Outcomes

NCT ID: NCT00950235

Last Updated: 2015-07-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Obesity Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type OTHER

Usual Care

Intervention Type OTHER

Standard nutrition counseling from Health Plan

Weight Management Counseling

In-person and group session counseling

Group Type EXPERIMENTAL

Weight Management

Intervention Type BEHAVIORAL

Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy

Interventions

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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

Intervention Type BEHAVIORAL

Usual Care

Standard nutrition counseling from Health Plan

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor J Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25164259 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22465256 (View on PubMed)

Other Identifiers

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1R01HD058061

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01HD058061-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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