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

NCT ID: NCT03215173

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Fit After Baby Group

Fit After Baby mobile health lifestyle intervention to increase postpartum weight loss, increase postpartum physical activity, and improve postpartum diet.

Group Type: EXPERIMENTAL

Fit After Baby

Intervention Type: BEHAVIORAL

Mobile application

Text4Baby Control Group

Receive text messages from the free Text4Baby program.

Group Type: ACTIVE_COMPARATOR

Text4Baby Control Group

Intervention Type: BEHAVIORAL

Receive free text messages

Interventions

Fit After Baby

Mobile application

Intervention Type: BEHAVIORAL

Text4Baby Control Group

Receive free text messages

Intervention Type: BEHAVIORAL

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacinda Nicklas, MD, MPH, MA

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

17-0045

Identifier Type: -

Identifier Source: org_study_id