Weight Management for Improved Pregnancy Outcomes

Study Overview
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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

Official Title
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Weight Management for Improved Pregnancy Outcomes

Conditions
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Obesity, Pregnancy

Intervention / Treatment
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* Behavioral: Weight Management
* Other: Usual Care


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Weight Change |  | baseline to 34 weeks gestation | 
| Large for Gestational Age (LGA) | Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth. | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obese, pregnant, large for gestational age, large for gestational age baby