Weight Management for Improved Pregnancy Outcomes (Healthy Moms)

June 11, 2015 updated by: Kaiser Permanente
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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center For Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Standard nutrition counseling from Health Plan
Experimental: Weight Management Counseling
In-person and group session counseling
Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 2 weeks post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Weight Change
Time Frame: baseline to 34 weeks gestation
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.
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Victor J Stevens, PhD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 1R01HD058061-01A1 (U.S. NIH Grant/Contract)
  • 1R01HD058061 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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