- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00950235
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
Intervention / Treatment
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.
Sponsor
Collaborators
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.
General Publications
- 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.
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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