Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

• ClinicalTrials.gov Identifier: NCT02142452
• Recruitment Status: Unknown
• First Posted: May 20, 2014
• Last Update Posted: April 20, 2016
• Sponsor: Stanford University
• Information provided by (Responsible Party): Sandra Anping Tsai, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; Weight Gain	Behavioral: behavioral intervention; Other: Usual Prenatal Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
• Study Start Date: March 2014
• Estimated Primary Completion Date: August 2016
• Estimated Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Placebo Comparator: 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.	Other: Usual Prenatal Care

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Stanford Hospital and Clinics

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Sandra A Tsai, MD; Stanford University

More Information

• Responsible Party: Sandra Anping Tsai, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02142452
• Other Study ID Numbers: 28810
• First Posted: May 20, 2014
• Last Update Posted: April 20, 2016
• Last Verified: April 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Sandra Anping Tsai, Stanford University:

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

Additional relevant MeSH terms:

Body Weight; Weight Gain; Gestational Weight Gain; Body Weight Changes