Weight Management for Improved Pregnancy Outcomes (Healthy Moms)

Kaiser Permanente

Status: Completed

Conditions: Obesity; Pregnancy

Treatments: Other: Usual Care; Behavioral: Weight Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00950235

1R01HD058061-01A1

1R01HD058061 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 118 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Usual Care

Other group

Description:

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

Treatment:

Other: Usual Care

Weight Management Counseling

Experimental group

Description:

In-person and group session counseling

Treatment:

Behavioral: Weight Management