University of Colorado
Aurora, Colorado, 80045, United States
NCT Number: NCT03215173
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.
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
include:
Mobile application
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Time frame: Baseline (~6 weeks), 6 months, and 12 months
Documentation of any change in weight at one year postpartum compared to weight at baseline, 6 weeks, 6 months and 12 months
Time frame: Pre-pregnancy, 6 weeks, 6 months, and 12 months
Documentation of any change in postpartum weight at one year postpartum compared to pre-pregnancy weight at 6 weeks, 6 months and 12 months
Time frame: Weekly from Baseline (~6 weeks) to 18 weeks postpartum and then at 6 months and 12 months postpartum
Subject satisfaction will be documented using a Likert scale
Time frame: Daily from Baseline to 18 weeks postpartum and then at 6 months and 12 months postpartum
Frequency
Time frame: Daily from Baseline to 12 months postpartum
Frequency
Time frame: Daily from Baseline to 12 months postpartum
Number
Time frame: Baseline to 6 months and to 12 months
Change in cm
Time frame: Baseline to 6 months and to 12 months
Change in mg/dL
Time frame: Baseline to 6 months and to 12 months
Change in %
Time frame: Baseline to 6 months and to 12 months
Change in fasting insulin
Time frame: Baseline to 6 months and to 12 months
Change in adiponectin
Time frame: Baseline to 6 months and to 12 months
HDL, LDL, Triglycerides
Time frame: Baseline to 6 months and to 12 months
Change in mmHg
Time frame: Baseline to 6 months and to 12 months
Change in hsCRP
Time frame: Baseline to 6 months and to 12 months
Edinburgh Postnatal Depression Scale
Time frame: Baseline to 6 months and to 12 months
Modified Pregnancy Physical Activity Questionnaire (PPAQ)
Time frame: Baseline to 6 months and to 12 months
Social Support for Eating Habits Survey; Social Support for Physical Activity
Time frame: Baseline to 6 months and to 12 months
Self Efficacy Survey for Diet and Exercise Behaviors
Time frame: Baseline to 6 months and to 12 months
Perceived Stress Scale
Time frame: Baseline to 6 months and to 12 months
2005 Block FFQ
Time frame: Baseline to 6 months and to 12 months
Breastfeeding frequency and intensity
Time frame: Baseline to 6 months and to 12 months
Readiness to Change Questionnaire
University of Colorado, Denver
Other
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
Acronym: FAB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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