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Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02142452
Enrollment
55
Registered
2014-05-20
Start date
2014-03-31
Completion date
2016-03-31
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Weight Gain

Keywords

Pregnancy, Obesity/Overweight, postpartum, mobile health, cardiovascular disease

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.

Interventions

BEHAVIORALbehavioral 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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
BMI (body mass index)4 months postpartumA 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

MeasureTime frameDescription
Cardiovascular health metrics4 months postpartum(1) Examine changes in cardiovascular health metrics (fasting glucose, fasting insulin, and BP) and markers of inflammation (hs-CRP) verses control group (2) We will evaluate changes in perceived nutrition, physical activity, and weight-loss self-efficacy; self-efficacy has been shown to be a direct predictor of behavior (3) measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.
Change in self efficacy score based on behavioral self-efficacy scale4 months postpartumWe will measure changes in pre- and post-intervention self-efficacy of all women in intervention and control arms.
Cardiovascular health metric4 months postpartumMeasure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026