Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Stanford University

Status: Completed

Conditions: Weight Gain; Pregnancy

Treatments: Behavioral: behavioral intervention; Other: Usual Prenatal Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02142452

28810

Details and patient eligibility

About

The investigators will test the efficacy of a tailored behavioral lifestyle modification program to support cardiovascular health in postpartum women with excessive gestational weight gain. This program will include a mobile health texting component postpartum to support changes in nutrition and physical activity. The investigators will randomize women into either the control arm (usual care) or the intervention (usual care + mobile health program postpartum). The women will be recruited during their 3rd trimester once they have been identified as gaining too much weight according to the 2009 IOM guidelines during pregnancy.

Enrollment: 55 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant woman diagnosed with excessive gestational weight at 24 weeks gestation or later
• Age 18 years or older
• English-speaking, and willing and able to participate in the proposed intervention.

Exclusion criteria

• Inability to provide informed consent and/or an inability to speak, read, or understand English
• Primary residence is outside of the immediate catchment area of 10 miles
• Physical or mental challenges that precludes them from exercising or returning for scheduled study follow ups
• Concurrent enrollment in another behavior modification program

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups, including a placebo group

mobile health intervention

Experimental group

Description:

Behavioral intervention. Women with excessive weight gain in pregnancy will be recruited in their 3rd trimester. They will begin with a 5 week group session on weight management. After they deliver the baby, they will begin receiving text messages supporting behavior change they learned in their 3rd trimester. They will follow up at 6 weeks postpartum and 4 months postpartum.

Treatment:

Behavioral: behavioral intervention

Control Group

Placebo Comparator group

Description:

Women will receive usual prenatal care from their OB. Postpartum, they will receive a monthly newsletter relevant to the new mother on her nutrition and physical activity. They will be followed at 6 weeks postpartum and 4 months postpartum.

Treatment:

Other: Usual Prenatal Care