NCT00950235

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 9, 2015

Completed
Last Updated

July 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

July 29, 2009

Results QC Date

May 28, 2015

Last Update Submit

June 11, 2015

Conditions

ObesityPregnancy

Keywords

obesepregnantlarge for gestational agelarge for gestational age baby

Outcome Measures

Primary Outcomes (1)

  • Maternal Weight Change

    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 Outcomes (2)

  • Pregnancy Weight Change

    baseline to 34 weeks gestation

  • Large for Gestational Age (LGA)

    At birth

Study Arms (2)

Usual Care

OTHER

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

Weight Management Counseling

EXPERIMENTAL

In-person and group session counseling

Behavioral: Weight Management

Interventions

Weight ManagementBEHAVIORAL

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

Weight Management Counseling
Usual CareOTHER

Standard nutrition counseling from Health Plan

Usual Care

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (2)

  • 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.

    PMID: 25164259DERIVED

  • 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.

    PMID: 22465256DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Victor J. Stevens, PhD Principle Investigator
Organization
Kaiser Permanente Center for Health Research
victor.j.stevens@kpchr.org
503 335 6751

Study Officials

  • Victor J Stevens, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 31, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

July 9, 2015

Results First Posted

July 9, 2015

Record last verified: 2015-06

Locations

US(1)