Weight Management for Improved Pregnancy Outcomes (Healthy Moms)
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ClinicalTrials.gov Identifier: NCT00950235 |
Recruitment Status
:
Completed
First Posted
: July 31, 2009
Results First Posted
: July 9, 2015
Last Update Posted
: July 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Pregnancy | Behavioral: Weight Management Other: Usual Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Weight Management for Improved Pregnancy Outcomes |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
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
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Experimental: Weight Management Counseling
In-person and group session counseling
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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
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- 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.
- Pregnancy Weight Change [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950235
United States, Oregon | |
Kaiser Permanente Center for Health Research | |
Portland, Oregon, United States, 97227 |
Principal Investigator: | Victor J Stevens, PhD | Kaiser Permanente |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00950235 History of Changes |
Other Study ID Numbers: |
1R01HD058061-01A1 ( U.S. NIH Grant/Contract ) 1R01HD058061 ( U.S. NIH Grant/Contract ) |
First Posted: | July 31, 2009 Key Record Dates |
Results First Posted: | July 9, 2015 |
Last Update Posted: | July 9, 2015 |
Last Verified: | June 2015 |
Keywords provided by Kaiser Permanente:
obese pregnant large for gestational age large for gestational age baby |