Clinical trial NCT03215173: Fit After Baby: Increasing Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Diabetes
Gestational Diabetes
Preeclampsia
Gestational Hypertension
Small for Gestational Age at Delivery
Preterm Birth
Overweight and Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled study
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18-45
2. Postpartum Body Mass Index (BMI): 26- 45 kg/m2 (≥24 for Asians)
3. Positive history of one or more of the following complications in most recent singleton or twin pregnancy:

   1. 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.
   2. Preeclampsia (high blood pressure and proteinuria diagnosed after 20 weeks gestation)
   3. Gestational hypertension (new hypertension diagnosed after 20 weeks without proteinuria)
   4. Pre-term delivery (32-37 weeks)
   5. Small for gestational age (\<10th percentile for gestational age)
4. Access to and be willing to use a wi-fi enabled iPhone (5 or higher) or iPod (5 or higher).
5. Capable of providing informed consent
6. Between 4 weeks and 16 weeks after delivery

Exclusion criteria include:

1. Personal history of Type 1 or 2 diabetes
2. Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer;
3. Personal history of major chronic illness all to be assessed by the study physician for ability to participate, including:

   1. cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication),
   2. kidney disease affecting kidney function severe enough to affect participation,
   3. liver disease affecting liver function severely enough to affect participation,
   4. venous or arterial thromboembolic disease,
   5. untreated adrenal insufficiency,
   6. depression requiring hospitalization within the past 6 months, or
   7. non-pregnancy related illness requiring overnight hospitalization in the past 6 months;
4. 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);
5. Re-current pregnancy;
6. Diagnosis of diseases associated with glucose metabolism;
7. Current or planned participation in a commercial weight loss program (i.e. Jenny Craig) over the duration of the study;
8. Previous or planned bariatric surgery;
9. Taking certain prescription medications including

   1. high dose glucocorticoids,
   2. atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or
   3. weight loss medications including prescription (Qsymia, phentermine, topiramate, Belviq, Contrave, Saxenda, Orlistat), or non-prescription (Alli) medications;
10. Taking metformin or other medications known to affect glucose metabolism;
11. Other active medical problems detected by examination or laboratory testing, at the discretion of the physician;
12. 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.

Primary outcomes:
measure: Change in weight loss from baseline to one year postpartum
timeFrame: Baseline (~6 weeks), 6 months, and 12 months
measure: Change in postpartum weight retention
timeFrame: Pre-pregnancy, 6 weeks, 6 months, and 12 months
Secondary outcomes:
measure: Evaluation of Subject Satisfaction
timeFrame: Weekly from Baseline (~6 weeks) to 18 weeks postpartum and then at 6 months and 12 months postpartum
measure: Adherence to self monitoring
timeFrame: Daily from Baseline to 18 weeks postpartum and then at 6 months and 12 months postpartum
measure: Use of app
timeFrame: Daily from Baseline to 12 months postpartum
measure: Number of interactions with lifestyle coach
timeFrame: Daily from Baseline to 12 months postpartum
measure: Change in waist circumference
timeFrame: Baseline to 6 months and to 12 months
measure: Change in fasting glucose
timeFrame: Baseline to 6 months and to 12 months
measure: Change in HbA1c
timeFrame: Baseline to 6 months and to 12 months
measure: Change in fasting insulin
timeFrame: Baseline to 6 months and to 12 months
measure: Change in adiponectin
timeFrame: Baseline to 6 months and to 12 months
measure: Change in lipids
timeFrame: Baseline to 6 months and to 12 months
measure: Change in blood pressure
timeFrame: Baseline to 6 months and to 12 months
measure: Change in hsCRP
timeFrame: Baseline to 6 months and to 12 months
measure: Change in postnatal depression score
timeFrame: Baseline to 6 months and to 12 months
measure: Change in Physical activity
timeFrame: Baseline to 6 months and to 12 months
measure: Change in Social Support
timeFrame: Baseline to 6 months and to 12 months
measure: Change in Self-Efficacy
timeFrame: Baseline to 6 months and to 12 months
measure: Change in Perceived Stress
timeFrame: Baseline to 6 months and to 12 months
measure: Change in dietary intake
timeFrame: Baseline to 6 months and to 12 months
measure: Change in breastfeeding status
timeFrame: Baseline to 6 months and to 12 months
measure: Change in Readiness to Change
timeFrame: Baseline to 6 months and to 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jacinda Nicklas, MD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References: