Fit After Baby: Increasing Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease

Study Overview
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Brief Summary
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This study plans to learn more about how to increase postpartum weight loss and how to decrease risk factors for postpartum women at increased risk for diabetes and heart disease. The program is delivered using a mobile application (app) and a lifestyle coach. This mobile application is developed for women who are at higher risk for diabetes and heart disease. Women who have gestational diabetes, (diabetes during pregnancy, or GDM), gestational hypertension (high blood pressure), and/or preeclampsia (high blood pressure and protein in the urine), and/or small-for gestational-age, and/or preterm (early) delivery during their pregnancies have a higher risk for diabetes and heart disease. This mobile application was developed using the latest research studies and using the evidence-based Diabetes Prevention and Colorado Weigh programs. The goal of the program is to help women lose weight and participate in physical activity after delivery.

Official Title
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Fit After Baby: A Randomized Controlled Trial of a Mobile Health Intervention to Increase Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease

Conditions
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Cardiovascular Diseases, Diabetes, Gestational Diabetes, Preeclampsia, Gestational Hypertension, Small for Gestational Age at Delivery, Preterm Birth, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Fit After Baby
* Behavioral: Text4Baby Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 Postpartum Body Mass Index (BMI): 26- 45 kg/m2 (≥24 for Asians) Positive history of one or more of the following complications in most recent singleton or twin pregnancy: Gestational diabetes mellitus (by Carpenter-Coustan criteria, IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, or a documented clinical diagnosis). Women with a glucose value >200 mg/dL after a 50-g glucose challenge test at >12 weeks gestation will also be included. Preeclampsia (high blood pressure and proteinuria diagnosed after 20 weeks gestation) Gestational hypertension (new hypertension diagnosed after 20 weeks without proteinuria) Pre-term delivery (32-37 weeks) Small for gestational age (<10th percentile for gestational age) Access to and be willing to use a wi-fi enabled iPhone (5 or higher) or iPod (5 or higher). Capable of providing informed consent Between 4 weeks and 16 weeks after delivery Exclusion criteria include: Personal history of Type 1 or 2 diabetes Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer; Personal history of major chronic illness all to be assessed by the study physician for ability to participate, including: cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease affecting kidney function severe enough to affect participation, liver disease affecting liver function severely enough to affect participation, venous or arterial thromboembolic disease, untreated adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months; Underlying disease/treatment that might interfere with participation in/completion of the study (e.g. significant gastrointestinal conditions, major psychiatric disorders affecting the ability to participate, and others at the discretion of the study clinician); Re-current pregnancy; Diagnosis of diseases associated with glucose metabolism; Current or planned participation in a commercial weight loss program (i.e. Jenny Craig) over the duration of the study; Previous or planned bariatric surgery; Taking certain prescription medications including high dose glucocorticoids, atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or weight loss medications including prescription (Qsymia, phentermine, topiramate, Belviq, Contrave, Saxenda, Orlistat), or non-prescription (Alli) medications; Taking metformin or other medications known to affect glucose metabolism; Other active medical problems detected by examination or laboratory testing, at the discretion of the physician; Any fasting blood glucose > 126 mg/dl, any HbA1c at or above 6.5%, or any plasma glucose >200 mg/dl during the first trimester.

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
Interventional Model Description: Randomized Controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fit After Baby Group<br>Fit After Baby mobile health lifestyle intervention to increase postpartum weight loss, increase postpartum physical activity, and improve postpartum diet. | Behavioral: Fit After Baby<br>* Mobile application<br>|
| Active Comparator: Text4Baby Control Group<br>Receive text messages from the free Text4Baby program. | Behavioral: Text4Baby Control Group<br>* Receive free text messages<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight loss from baseline to one year postpartum | Documentation of any change in weight at one year postpartum compared to weight at baseline, 6 weeks, 6 months and 12 months | Baseline ( 6 weeks), 6 months, and 12 months | 
| Change in postpartum weight retention | Documentation of any change in postpartum weight at one year postpartum compared to pre-pregnancy weight at 6 weeks, 6 months and 12 months | Pre-pregnancy, 6 weeks, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Subject Satisfaction | Subject satisfaction will be documented using a Likert scale | Weekly from Baseline ( 6 weeks) to 18 weeks postpartum and then at 6 months and 12 months postpartum | 
| Adherence to self monitoring | Frequency | Daily from Baseline to 18 weeks postpartum and then at 6 months and 12 months postpartum | 
| Use of app | Frequency | Daily from Baseline to 12 months postpartum | 
| Number of interactions with lifestyle coach | Number | Daily from Baseline to 12 months postpartum | 
| Change in waist circumference | Change in cm | Baseline to 6 months and to 12 months | 
| Change in fasting glucose | Change in mg/dL | Baseline to 6 months and to 12 months | 
| Change in HbA1c | Change in % | Baseline to 6 months and to 12 months | 
| Change in fasting insulin | Change in fasting insulin | Baseline to 6 months and to 12 months | 
| Change in adiponectin | Change in adiponectin | Baseline to 6 months and to 12 months | 
| Change in lipids | HDL, LDL, Triglycerides | Baseline to 6 months and to 12 months | 
| Change in blood pressure | Change in mmHg | Baseline to 6 months and to 12 months | 
| Change in hsCRP | Change in hsCRP | Baseline to 6 months and to 12 months | 
| Change in postnatal depression score | Edinburgh Postnatal Depression Scale | Baseline to 6 months and to 12 months | 
| Change in Physical activity | Modified Pregnancy Physical Activity Questionnaire (PPAQ) | Baseline to 6 months and to 12 months | 
| Change in Social Support | Social Support for Eating Habits Survey; Social Support for Physical Activity | Baseline to 6 months and to 12 months | 
| Change in Self-Efficacy | Self Efficacy Survey for Diet and Exercise Behaviors | Baseline to 6 months and to 12 months | 
| Change in Perceived Stress | Perceived Stress Scale | Baseline to 6 months and to 12 months | 
| Change in dietary intake | 2005 Block FFQ | Baseline to 6 months and to 12 months | 
| Change in breastfeeding status | Breastfeeding frequency and intensity | Baseline to 6 months and to 12 months | 
| Change in Readiness to Change | Readiness to Change Questionnaire | Baseline to 6 months and to 12 months |