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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03215173

Run by

University of Colorado, Denver

People needed

82

Starts

2017-09-01

Expected to finish

2020-11-30

Last updated by the study team

2021-03-08

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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;

Where it is running

• University of Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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