Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Not Applicable

Completed

• Conditions: Pregnancy; Weight Gain
• Interventions: Behavioral: behavioral intervention; Other: Usual Prenatal Care

• Registration Number: NCT02142452
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-20
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mobile health intervention	behavioral 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.
Control Group	Usual Prenatal Care	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.

Primary Outcome Measures

Name	Time	Method
BMI (body mass index)	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 Outcome Measures

Name	Time	Method
Cardiovascular health metrics	4 months postpartum	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
Change in self efficacy score based on behavioral self-efficacy scale	4 months postpartum	We will measure changes in pre- and post-intervention self-efficacy of all women in intervention and control arms.
Cardiovascular health metric	4 months postpartum	Measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States