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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fit After Baby Group | Experimental | Fit After Baby mobile health lifestyle intervention to increase postpartum weight loss, increase postpartum physical activity, and improve postpartum diet. |
|
| Text4Baby Control Group | Active Comparator | Receive text messages from the free Text4Baby program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fit After Baby | Behavioral | Mobile application |
| |
| 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 |
| 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 |
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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:
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:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jacinda Nicklas, MD, MPH, MA | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
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Randomized Controlled study
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| Text4Baby Control Group |
| Behavioral |
Receive free text messages |
|
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 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D016640 | Diabetes, Gestational |
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| D047928 | Premature Birth |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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