Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Pregnancy Clinical Trial

Official title:

Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142452
• Other study ID #: 28810
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Pregnancy
• Weight Gain

Intervention

Behavioral:
• 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.

Other:
• Usual Prenatal Care

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI (body mass index)	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.	4 months postpartum
Secondary	Cardiovascular health metrics	(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.	4 months postpartum
Secondary	Change in self efficacy score based on behavioral self-efficacy scale	We will measure changes in pre- and post-intervention self-efficacy of all women in intervention and control arms.	4 months postpartum
Secondary	Cardiovascular health metrics	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	4 months postpartum
Secondary	Cardiovascular health metric	Measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.	4 months postpartum