Cardiovascular DiseasesFABNCT03215173

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

A study testing Fit After Baby in people with Cardiovascular Diseases and Diabetes, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases, Diabetes, Gestational Diabetes
What is being tested?: Fit After Baby
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2017to 30 Nov 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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)

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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

Who cannot join

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,

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado
Aurora, Colorado, 80045

Other trials in United States

About this study

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

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
Being tested: Fit After Baby, Text4Baby Control Group
Medical subject headings: Cardiovascular Diseases, Diabetes Mellitus, Diabetes, Gestational, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Premature Birth, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fit After BabyBehavioural
Mobile application
Text4Baby Control GroupBehavioural
Receive free text messages

Study groups in NCT03215173
Study group	Role	What they receive
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. Receives: Behavioral: Fit After Baby
Text4Baby Control Group	Active comparator	Receive text messages from the free Text4Baby program. Receives: Behavioral: Text4Baby Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Pre-pregnancy, 6 weeks, 6 months, and 12 months

Secondary outcomes (20)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201730 Nov 2020

First posted12 Jul 2017
Study start1 Sep 2017
Primary completion30 Nov 2020
Study completion30 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized Controlled study
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03215173
Sponsor's protocol ID: 17-0045
Acronym: FAB
Status last verified: Mar 2021
First submitted: 29 Jun 2017
Last updated: 8 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03215173
Acronym / sponsor ID: FAB / 17-0045
Conditions: Cardiovascular Diseases, Diabetes, Gestational Diabetes, Preeclampsia, Gestational Hypertension, Small for Gestational Age at Delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 1 Sep 2017 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 30 Nov 2020 (actual)
First posted: 12 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized Controlled study

Arm	Type	Receives
Fit After Baby Group	Experimental	Behavioral: Fit After BabyFit After Baby mobile health lifestyle intervention to increase postpartum weight loss, increase postpartum physical activity, and improve postpartum diet.
Text4Baby Control Group	Active comparator	Behavioral: Text4Baby Control GroupReceive text messages from the free Text4Baby program.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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:
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

Key exclusion criteria (22 listed)

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:
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fit After BabyMobile application	Behavioural	Fit After Baby Group
Text4Baby Control GroupReceive free text messages	Behavioural	Text4Baby Control Group

Primary outcome

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
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

20 secondary outcomes

Evaluation of Subject Satisfaction
Time frame: 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
Use of app
Time frame: Daily from Baseline to 12 months postpartum
Number of interactions with lifestyle coach
Time frame: Daily from Baseline to 12 months postpartum
Change in waist circumference
Time frame: Baseline to 6 months and to 12 months
Change in fasting glucose
Time frame: Baseline to 6 months and to 12 months
Change in HbA1c
Time frame: Baseline to 6 months and to 12 months
Change in fasting insulin
Time frame: Baseline to 6 months and to 12 months
Change in adiponectin
Time frame: Baseline to 6 months and to 12 months
Change in lipids
Time frame: Baseline to 6 months and to 12 months
Change in blood pressure
Time frame: Baseline to 6 months and to 12 months
Change in hsCRP
Time frame: Baseline to 6 months and to 12 months
Change in postnatal depression score
Time frame: Baseline to 6 months and to 12 months
Change in Physical activity
Time frame: Baseline to 6 months and to 12 months
Change in Social Support
Time frame: Baseline to 6 months and to 12 months
Change in Self-Efficacy
Time frame: Baseline to 6 months and to 12 months
Change in Perceived Stress
Time frame: Baseline to 6 months and to 12 months
Change in dietary intake
Time frame: Baseline to 6 months and to 12 months
Change in breastfeeding status
Time frame: Baseline to 6 months and to 12 months
Change in Readiness to Change
Time frame: Baseline to 6 months and to 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacinda Nicklas, MD, MPH, MA principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fit After Baby in people with Cardiovascular Diseases and Diabetes, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight loss from baseline to one year postpartum (time frame: Baseline (~6 weeks), 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03215173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.