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Fit After Baby: A Health Intervention to Increase Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease (FAB)

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ClinicalTrials.gov Identifier: NCT03215173
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diabetes Gestational Diabetes Preeclampsia Gestational Hypertension Small for Gestational Age at Delivery Preterm Birth Overweight and Obesity Behavioral: Fit After Baby Behavioral: Text4Baby Control Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fit After Baby Group
Fit After Baby mobile health lifestyle intervention to increase postpartum weight loss, increase postpartum physical activity, and improve postpartum diet.
Behavioral: Fit After Baby
Mobile application
Active Comparator: Text4Baby Control Group
Receive text messages from the free Text4Baby program.
Behavioral: Text4Baby Control Group
Receive free text messages



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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 include:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215173


Contacts
Contact: Jacinda Nicklas, MD, MPH, MA (303)724-9028 jacinda.nicklas@ucdenver.edu

Locations
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jacinda Nicklas, MD, MPH, MA    303-724-9028    jacinda.nicklas@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jacinda Nicklas, MD, MPH, MA University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03215173     History of Changes
Other Study ID Numbers: 17-0045
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Hypertension
Diabetes Mellitus
Cardiovascular Diseases
Overweight
Weight Loss
Diabetes, Gestational
Pre-Eclampsia
Premature Birth
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Body Weight Changes
Obstetric Labor, Premature
Obstetric Labor Complications
Vascular Diseases