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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Weight Gain||Behavioral: behavioral intervention Other: Usual Prenatal Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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
- 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.
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
|United States, California|
|Stanford Hospital and Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sandra A Tsai, MD||Stanford University|