Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Study Overview
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Brief Summary
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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.

Official Title
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Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

Conditions
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Pregnancy, Weight Gain

Intervention / Treatment
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* Behavioral: behavioral intervention
* Other: Usual Prenatal Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mobile health intervention<br>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<br>* Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.<br>|
| Placebo Comparator: Control Group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Cardiovascular health metric | Measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group. | 4 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health, cardiovascular disease, Pregnancy, Obesity/Overweight, postpartum