Back to resultsCardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Primary Purpose
Pregnancy, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
behavioral intervention
Usual Prenatal Care
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, Obesity/Overweight, postpartum, mobile health, cardiovascular disease
Eligibility 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
Sites / Locations
- Stanford Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
mobile health intervention
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Cardiovascular health metric
Measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02142452
Brief Title
Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Official Title
Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Weight Gain
Keywords
Pregnancy, Obesity/Overweight, postpartum, mobile health, cardiovascular disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mobile health intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Intervention Description
Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.
Intervention Type
Other
Intervention Name(s)
Usual Prenatal Care
Primary Outcome Measure Information:
Title
BMI (body mass index)
Description
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.
Time Frame
4 months postpartum
Secondary Outcome Measure Information:
Title
Cardiovascular health metrics
Description
(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.
Time Frame
4 months postpartum
Title
Change in self efficacy score based on behavioral self-efficacy scale
Description
We will measure changes in pre- and post-intervention self-efficacy of all women in intervention and control arms.
Time Frame
4 months postpartum
Title
Cardiovascular health metrics
Description
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
Time Frame
4 months postpartum
Title
Cardiovascular health metric
Description
Measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.
Time Frame
4 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra A Tsai, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
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