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

NCT03215173 | Completed

• 1 other identifier: 17-0045
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Diabetes; Gestational Diabetes; Preeclampsia; Gestational Hypertension; Small for Gestational Age at Delivery; Preterm Birth; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Evaluation of Subject Satisfaction

  Weekly from Baseline (~6 weeks) to 18 weeks postpartum and then at 6 months and 12 months postpartum

• Adherence to self monitoring

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

• Use of app

  Daily from Baseline to 12 months postpartum

• Number of interactions with lifestyle coach

  Daily from Baseline to 12 months postpartum

• Change in waist circumference

  Baseline to 6 months and to 12 months

Study Arms (2)

Fit After Baby Group

EXPERIMENTAL

Fit After Baby mobile health lifestyle intervention to increase postpartum weight loss, increase postpartum physical activity, and improve postpartum diet.

Behavioral: Fit After Baby

Text4Baby Control Group

ACTIVE COMPARATOR

Receive text messages from the free Text4Baby program.

Behavioral: Text4Baby Control Group

Interventions

Fit After Baby BEHAVIORAL

Mobile application

Fit After Baby Group

Text4Baby Control Group BEHAVIORAL

Receive free text messages

Text4Baby Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Diabetes, Gestational; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Premature Birth; Overweight; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacinda Nicklas, MD, MPH, MA

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled study

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 12, 2017
• Study Start: September 1, 2017
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)