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Fit After Baby: Increasing Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03215173•University of Colorado, Denver

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

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
+1 more criteria

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;
+12 more criteria

Locations (1)

University of Colorado

Aurora, Colorado, United States

Key Dates

Start Date

September 1, 2017

Primary Completion Date

November 30, 2020

Completion Date

November 30, 2020

Last Updated

March 8, 2021

Enrollment

ACTUAL participants

Conditions

Cardiovascular DiseasesDiabetesGestational DiabetesPreeclampsiaGestational HypertensionSmall for Gestational Age at DeliveryPreterm BirthOverweight and Obesity

Interventions

Fit After Baby

BEHAVIORAL

Text4Baby Control Group

BEHAVIORAL

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

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RECRUITINGNA

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NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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