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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes; Preterm Birth; Overweight and Obesity; Preeclampsia; Gestational Diabetes; Small for Gestational Age at Delivery; Gestational Hypertension
• Intervention / Treatment: Behavioral: Fit After Baby; Behavioral: Text4Baby Control Group

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight loss from baseline to one year postpartum	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	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

Outcome Measure	Measure Description	Time Frame
Evaluation of Subject Satisfaction	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	Frequency	Daily from Baseline to 18 weeks postpartum and then at 6 months and 12 months postpartum
Use of app	Frequency	Daily from Baseline to 12 months postpartum
Number of interactions with lifestyle coach	Number	Daily from Baseline to 12 months postpartum
Change in waist circumference	Change in cm	Baseline to 6 months and to 12 months
Change in fasting glucose	Change in mg/dL	Baseline to 6 months and to 12 months
Change in HbA1c	Change in %	Baseline to 6 months and to 12 months
Change in fasting insulin	Change in fasting insulin	Baseline to 6 months and to 12 months
Change in adiponectin	Change in adiponectin	Baseline to 6 months and to 12 months
Change in lipids	HDL, LDL, Triglycerides	Baseline to 6 months and to 12 months
Change in blood pressure	Change in mmHg	Baseline to 6 months and to 12 months
Change in hsCRP	Change in hsCRP	Baseline to 6 months and to 12 months
Change in postnatal depression score	Edinburgh Postnatal Depression Scale	Baseline to 6 months and to 12 months
Change in Physical activity	Modified Pregnancy Physical Activity Questionnaire (PPAQ)	Baseline to 6 months and to 12 months
Change in Social Support	Social Support for Eating Habits Survey; Social Support for Physical Activity	Baseline to 6 months and to 12 months
Change in Self-Efficacy	Self Efficacy Survey for Diet and Exercise Behaviors	Baseline to 6 months and to 12 months
Change in Perceived Stress	Perceived Stress Scale	Baseline to 6 months and to 12 months
Change in dietary intake	2005 Block FFQ	Baseline to 6 months and to 12 months
Change in breastfeeding status	Breastfeeding frequency and intensity	Baseline to 6 months and to 12 months
Change in Readiness to Change	Readiness to Change Questionnaire	Baseline to 6 months and to 12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jacinda Nicklas, MD, MPH, MA, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

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: 17-0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No