Preventing Excessive Gestational Weight Gain in Obese Women

California Polytechnic State University (Cal Poly)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01545934

U01 HL114377A

Details and patient eligibility

About

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

Enrollment: 264 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 18 years old
• < 16 weeks gestation
• BMI >= 25
• Willing to consent

Exclusion criteria

• Pregnant with Twins
• Untreated medical or psychological problem
• Inability to be physically active

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

Standard Care

No Intervention group

Lifestyle intervention

Experimental group

Treatment:

Behavioral: Lifestyle intervention