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OpenTrials
Completed

NCT Number: NCT03215173

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

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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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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;
  • 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
  • high dose glucocorticoids,
  • atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or
  • weight loss medications including prescription (Qsymia, phentermine, topiramate, Belviq, Contrave, Saxenda, Orlistat), or non-prescription (Alli) medications;
  • 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.

Treatment and study plan

Fit After Baby

Behavioral

Mobile application

Text4Baby Control Group

Behavioral

Receive free text messages

Primary outcomes

  1. Change in weight loss from baseline to one year postpartum

    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

  2. Change in postpartum weight retention

    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

Secondary outcomes

  1. Evaluation of Subject Satisfaction

    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

  2. Adherence to self monitoring

    Time frame: Daily from Baseline to 18 weeks postpartum and then at 6 months and 12 months postpartum

    Frequency

  3. Use of app

    Time frame: Daily from Baseline to 12 months postpartum

    Frequency

  4. Number of interactions with lifestyle coach

    Time frame: Daily from Baseline to 12 months postpartum

    Number

  5. Change in waist circumference

    Time frame: Baseline to 6 months and to 12 months

    Change in cm

  6. Change in fasting glucose

    Time frame: Baseline to 6 months and to 12 months

    Change in mg/dL

  7. Change in HbA1c

    Time frame: Baseline to 6 months and to 12 months

    Change in %

  8. Change in fasting insulin

    Time frame: Baseline to 6 months and to 12 months

    Change in fasting insulin

  9. Change in adiponectin

    Time frame: Baseline to 6 months and to 12 months

    Change in adiponectin

  10. Change in lipids

    Time frame: Baseline to 6 months and to 12 months

    HDL, LDL, Triglycerides

  11. Change in blood pressure

    Time frame: Baseline to 6 months and to 12 months

    Change in mmHg

  12. Change in hsCRP

    Time frame: Baseline to 6 months and to 12 months

    Change in hsCRP

  13. Change in postnatal depression score

    Time frame: Baseline to 6 months and to 12 months

    Edinburgh Postnatal Depression Scale

  14. Change in Physical activity

    Time frame: Baseline to 6 months and to 12 months

    Modified Pregnancy Physical Activity Questionnaire (PPAQ)

  15. Change in Social Support

    Time frame: Baseline to 6 months and to 12 months

    Social Support for Eating Habits Survey; Social Support for Physical Activity

  16. Change in Self-Efficacy

    Time frame: Baseline to 6 months and to 12 months

    Self Efficacy Survey for Diet and Exercise Behaviors

  17. Change in Perceived Stress

    Time frame: Baseline to 6 months and to 12 months

    Perceived Stress Scale

  18. Change in dietary intake

    Time frame: Baseline to 6 months and to 12 months

    2005 Block FFQ

  19. Change in breastfeeding status

    Time frame: Baseline to 6 months and to 12 months

    Breastfeeding frequency and intensity

  20. Change in Readiness to Change

    Time frame: Baseline to 6 months and to 12 months

    Readiness to Change Questionnaire

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2017
Registry last updated
Mar 8, 2021

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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