Empowering Mindfulness, Body Respect, and Compassionate Eating Among Women Who Binge Eat During Pregnancy

May 3, 2026 updated by: Jennifer B. Webb, Ph.D., University of North Carolina, Charlotte

EMBRACE MOMS 2 BE: A Pilot Feasibility, Acceptability, and Preliminary Efficacy Study of a Mindful Eating Self-Help Program for Women Who Binge Eat During Pregnancy

Primary Study Aims:

  1. To evaluate the feasibility, acceptability, and preliminary efficacy of a 10-week mindful eating self-help program for women who binge eat during pregnancy. Primary efficacy targets will include measures of mindful eating and binge eating. Secondary efficacy targets will involve measures of body image and well-being.
  2. To evaluate the incremental utility of adding use of a companion mindful eating smart phone application for enhancing the acceptability and preliminary efficacy of the program.
  3. To gain insights into ways in which this program may be better tailored to the experiences of pregnancy for future program adaptation and refinement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Research suggests that binge eating during pregnancy may adversely impact maternal-child health and well-being. For example, clinical evidence cites binge eating as a risk factor for increased gestational weight gain, cesarean delivery, giving birth to infants who are large for gestational age (LGA), and is associated with additional maternal susceptibility for cardiometabolic dysregulation and its complications at this critical maturational period . Nevertheless, surprisingly despite the growth in epidemiological investigations of eating disorders during pregnancy, no studies to date have specifically evaluated a behavioral intervention during pregnancy to address binge eating concerns within this population. Therefore, there is significant need to address this gap in order to develop, evaluate, and disseminate evidence-based behavioral interventions for women struggling with binge eating during pregnancy. One growing area of scholarship is implementing self-help approaches as a means of increasing availability to evidence-based behavioral health interventions for individuals who may not otherwise be able to access these treatments. At the same time, interventions that incorporate mindful eating have recently shown promise as an effective intervention for reducing binge eating and overeating in a wide range of clinical and community samples. These interventions most often conducted over a period ranging between 6-20 weeks of varying formats (e.g., group, in-person versus combination with remote support, etc.), and intensities (e.g., weekly versus bi-weekly, etc.), typically introduce participants to the concepts of mindfulness, provide opportunities to engage in mindfulness meditation practices, apply mindfulness skills to the process of eating via eating-related meditations and other similar exercises including appetite awareness training and encourage between-session home practice. The Am I Hungry? Mindful Eating Program for Binge Eating was used as a model for the present study. In the original pilot investigation a sample of women with binge eating disorder engaged in a 10-week group mindful eating-based treatment program. Results indicated significant reductions in binge eating severity and psychological distress by the final assessment period which were sustained at 1-year follow-up. We have adapted this approach in order to evaluate it in a guided self-help format with and without access to a companion smartphone application and among other things to directly assess not only changes in binge eating but also those related to more adaptive eating processes such as mindful and intuitive eating styles.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28223
        • UNC Charlotte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • female (assigned sex at birth)
  • able to read and write in English
  • between the ages of 18-40
  • lives in the United States
  • between 13-16 weeks pregnant (gestation) with a singleton
  • owns an iPhone or iPad
  • reports engaging in recurrent binge eating (i.e., reporting engaging in at least 1 binge eating episode per week for the last 28 days according to the EDE-Qi)
  • has access to a computer or tablet with Internet
  • being regularly followed by a healthcare provider during their pregnancy

Exclusion Criteria:

  • reports current smoking or substance abuse
  • reports elevated depression (i.e., a score of 13 or higher on the EPDS)
  • reports current suicidal ideation (assessed on the EPDS)
  • reports anorexia, purging or compensatory behavior (both assessed on the EDE-Qi)
  • reports a history of being hospitalized for mental health treatment in the last 6 months
  • reports use of medications that are taken to affect appetite or metabolism (e.g., insulin)
  • is currently in therapy for treating binge eating
  • reports serious cardiovascular morbidity (e.g., hypertension)
  • reports uncontrolled or untreated thyroid disease
  • reports a history of 3 or more miscarriages, weakened cervix, or persistent bleeding during the first 12 weeks of pregnancy
  • reports being unable to commit to participate fully in the 10-week program (i.e., read from the self-help book weekly, utilize the smartphone application daily, submit weekly logs of their experiences)
  • individuals seeking a dieting approach to weight management during pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Mindful Eating Self-Help Book Only
Participants will be invited to read about and practice a variety of mindful eating-related strategies over the course of 10 weeks based on Dr. Michelle May & Dr. Kari Anderson's self-help book entitled, "Eat What You Love, Love What You Eat for Binge Eating". Participants will also be asked to complete a weekly electronic log describing their experiences with the weekly mindfulness-based practices.
Behavioral: Mindful Eating Self-Help Program
10-week exposure to mindful eating principles and practices outlined in the Eat What You Love, Love What You Eat for Binge Eating book
Experimental: Mindful Eating Self-Help Book + Smartphone App
Participants will be invited to read about and practice a variety of mindful eating-related strategies over the course of 10 weeks based on Dr. Michelle May & Dr. Kari Anderson's self-help book entitled, "Eat What You Love, Love What You Eat for Binge Eating". In addition, participants will be asked to use the companion Am I Hungry? Mindful Eating Virtual Coach smartphone application three times daily. Participants will also be asked to complete a weekly electronic log describing their experiences with the weekly mindfulness-based practices.
Behavioral: Mindful Eating Self-Help Program
10-week exposure to mindful eating principles and practices outlined in the Eat What You Love, Love What You Eat for Binge Eating book
Behavioral: Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)
10-week exposure to using a mindful eating mobile phone application daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mindful Eating
Time Frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Mindful Eating Inventory (MEI)
baseline, after week 5 (midpoint), after week 10 (immediate post)
Binge Eating
Time Frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi)
baseline, after week 5 (midpoint), after week 10 (immediate post)
Intuitive Eating
Time Frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Intuitive Eating Scale-2 (IES-2)
baseline, after week 5 (midpoint), after week 10 (immediate post)
Enrollment
Time Frame: 6 months after opening enrollment
percent enrollment within 6 months of opening recruitment
6 months after opening enrollment
Attrition
Time Frame: throughout the 10-week program
percent of participants who dropped out
throughout the 10-week program
Program Satisfaction
Time Frame: after week 10
participant satisfaction questionnaire
after week 10
App Usability
Time Frame: after week 10
app usability questionnaire
after week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Image
Time Frame: baseline, after week 5 (midpoint), after week 10 (post-program)
Body Image in Pregnancy Scale (BIPS)
baseline, after week 5 (midpoint), after week 10 (post-program)
General Well-being
Time Frame: baseline, after week 5 (midpoint), after week 10 (post-program)
General Well-being: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
baseline, after week 5 (midpoint), after week 10 (post-program)
COVID-19-related Well-being
Time Frame: baseline, after week 5 (midpoint), after week 10 (post-program)
Perinatal COVID-19-related Well-being (COPE-IU)
baseline, after week 5 (midpoint), after week 10 (post-program)
Mindful Self-Care
Time Frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Mindful Self-Care Scale (MSCS)
baseline, after week 5 (midpoint), after week 10 (immediate post)
Weight Bias Internalization
Time Frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Weight Bias Internalization Scale-Modified (WBIS-M)
baseline, after week 5 (midpoint), after week 10 (immediate post)
Physical Activity
Time Frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
baseline, after week 5 (midpoint), after week 10 (immediate post)
Depression
Time Frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Edinburgh Postnatal Depression Scale (EPDS)
baseline, after week 5 (midpoint), after week 10 (immediate post)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Charlotte

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer B Webb, PhD, UNC Charlotte
  • Principal Investigator: V Gil-Rivas, PhD, UNC Charlotte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRBIS-19-0680

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

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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