Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- BMI (body mass index)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: behavioral intervention (Behavioral)
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.
Intervention: Usual Prenatal Care (Other)
Outcomes
Primary Outcomes
BMI (body mass index)
Time Frame: 4 months postpartum
A mobile Health intervention tailored for the 30 postpartum mother and grounded in behavioral change theory will be associated with significantly more reduction in BMI than 30 women not enrolled in the intervention.
Secondary Outcomes
- Cardiovascular health metrics(4 months postpartum)
- Change in self efficacy score based on behavioral self-efficacy scale(4 months postpartum)
- Cardiovascular health metric(4 months postpartum)
Investigators
Sandra Anping Tsai
Principal Investigator
Stanford University