Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

NCT ID: NCT02142452

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Pregnancy; Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

mobile health intervention

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.

Group Type: EXPERIMENTAL

behavioral intervention

Intervention Type: BEHAVIORAL

Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Usual Prenatal Care

Intervention Type: OTHER

Interventions

behavioral intervention

Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.

Intervention Type: BEHAVIORAL

Usual Prenatal Care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sandra Anping Tsai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra A Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Hospital and Clinics

Stanford, California, United States

Countries

United States

Other Identifiers

28810

Identifier Type: -

Identifier Source: org_study_id