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Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

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ClinicalTrials.gov Identifier: NCT02142452
Recruitment Status : Unknown
Verified April 2016 by Sandra Anping Tsai, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Sandra Anping Tsai, 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.

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

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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

Resource links provided by the National Library of Medicine


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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142452


Locations
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United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sandra A Tsai, MD Stanford University
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Responsible Party: Sandra Anping Tsai, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02142452    
Other Study ID Numbers: 28810
First Posted: May 20, 2014    Key Record Dates
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:
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Body Weight
Weight Gain
Gestational Weight Gain
Body Weight Changes