Fit After Baby: Increasing Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease (FAB)
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
|
Mobile application
|
|
Active Comparator: Text4Baby Control Group
Receive text messages from the free Text4Baby program.
|
Receive free text messages
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline (~6 weeks), 6 months, and 12 months
|
|
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
|
Pre-pregnancy, 6 weeks, 6 months, and 12 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Weekly from Baseline (~6 weeks) to 18 weeks postpartum and then at 6 months and 12 months postpartum
|
|
Adherence to self monitoring
Time Frame: Daily from Baseline to 18 weeks postpartum and then at 6 months and 12 months postpartum
|
Frequency
|
Daily from Baseline to 18 weeks postpartum and then at 6 months and 12 months postpartum
|
|
Use of app
Time Frame: Daily from Baseline to 12 months postpartum
|
Frequency
|
Daily from Baseline to 12 months postpartum
|
|
Number of interactions with lifestyle coach
Time Frame: Daily from Baseline to 12 months postpartum
|
Number
|
Daily from Baseline to 12 months postpartum
|
|
Change in waist circumference
Time Frame: Baseline to 6 months and to 12 months
|
Change in cm
|
Baseline to 6 months and to 12 months
|
|
Change in fasting glucose
Time Frame: Baseline to 6 months and to 12 months
|
Change in mg/dL
|
Baseline to 6 months and to 12 months
|
|
Change in HbA1c
Time Frame: Baseline to 6 months and to 12 months
|
Change in %
|
Baseline to 6 months and to 12 months
|
|
Change in fasting insulin
Time Frame: Baseline to 6 months and to 12 months
|
Change in fasting insulin
|
Baseline to 6 months and to 12 months
|
|
Change in adiponectin
Time Frame: Baseline to 6 months and to 12 months
|
Change in adiponectin
|
Baseline to 6 months and to 12 months
|
|
Change in lipids
Time Frame: Baseline to 6 months and to 12 months
|
HDL, LDL, Triglycerides
|
Baseline to 6 months and to 12 months
|
|
Change in blood pressure
Time Frame: Baseline to 6 months and to 12 months
|
Change in mmHg
|
Baseline to 6 months and to 12 months
|
|
Change in hsCRP
Time Frame: Baseline to 6 months and to 12 months
|
Change in hsCRP
|
Baseline to 6 months and to 12 months
|
|
Change in postnatal depression score
Time Frame: Baseline to 6 months and to 12 months
|
Edinburgh Postnatal Depression Scale
|
Baseline to 6 months and to 12 months
|
|
Change in Physical activity
Time Frame: Baseline to 6 months and to 12 months
|
Modified Pregnancy Physical Activity Questionnaire (PPAQ)
|
Baseline to 6 months and to 12 months
|
|
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
|
Baseline to 6 months and to 12 months
|
|
Change in Self-Efficacy
Time Frame: Baseline to 6 months and to 12 months
|
Self Efficacy Survey for Diet and Exercise Behaviors
|
Baseline to 6 months and to 12 months
|
|
Change in Perceived Stress
Time Frame: Baseline to 6 months and to 12 months
|
Perceived Stress Scale
|
Baseline to 6 months and to 12 months
|
|
Change in dietary intake
Time Frame: Baseline to 6 months and to 12 months
|
2005 Block FFQ
|
Baseline to 6 months and to 12 months
|
|
Change in breastfeeding status
Time Frame: Baseline to 6 months and to 12 months
|
Breastfeeding frequency and intensity
|
Baseline to 6 months and to 12 months
|
|
Change in Readiness to Change
Time Frame: Baseline to 6 months and to 12 months
|
Readiness to Change Questionnaire
|
Baseline to 6 months and to 12 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jacinda Nicklas, MD, MPH, MA, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Body Weight
- Pregnancy Complications
- Obstetric Labor Complications
- Body Weight Changes
- Obstetric Labor, Premature
- Hypertension
- Cardiovascular Diseases
- Diabetes Mellitus
- Weight Loss
- Premature Birth
- Overweight
- Pre-Eclampsia
- Diabetes, Gestational
- Hypertension, Pregnancy-Induced
Other Study ID Numbers
Other Study ID Numbers
- 17-0045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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