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

Not Applicable

Completed

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

• Registration Number: NCT03215173
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Study Start: 2017-09-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text4Baby Control Group	Text4Baby Control Group	Receive text messages from the free Text4Baby program.
Fit After Baby Group	Fit After Baby	Fit After Baby mobile health lifestyle intervention to increase postpartum weight loss, increase postpartum physical activity, and improve postpartum diet.

Primary Outcome Measures

Name	Time	Method
Change in postpartum weight retention	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
Change in weight loss from baseline to one year postpartum	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States