PregnancyNCT05581095
Empowering Mindfulness, Body Respect, and Compassionate Eating Among Women Who Binge Eat During Pregnancy
A study testing Mindful Eating Self-Help Program and Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach) in people with Pregnancy and Binge Eating, run by University of North Carolina, Charlotte at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Binge Eating
- What is being tested?
- Mindful Eating Self-Help Program and Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2024to 10 Mar 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- 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.
- To gain insights into ways in which this program may be better tailored to the experiences of pregnancy for future program adaptation and refinement.
Read the 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.
- Conditions
- Pregnancy, Binge Eating
- Being tested
- Mindful Eating Self-Help Program, Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)
- Medical subject headings
- Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Eating Self-Help ProgramBehavioural
10-week exposure to mindful eating principles and practices outlined in the Eat What You Love, Love What You Eat for Binge Eating book
Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)Behavioural
10-week exposure to using a mindful eating mobile phone application daily.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Eating Self-Help Book Only | Active comparator | 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. Receives: Behavioral: Mindful Eating Self-Help Program |
| Mindful Eating Self-Help Book + Smartphone App | Experimental | 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. Receives: Behavioral: Mindful Eating Self-Help Program; Behavioral: Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
percent enrollment within 6 months of opening recruitment
Measured: 6 months after opening enrollment
Attrition
percent of participants who dropped out
Measured: throughout the 10-week program
Program Satisfaction
participant satisfaction questionnaire
Measured: after week 10
App Usability
app usability questionnaire
Measured: after week 10
Mindful Eating
Mindful Eating Inventory (MEI)
Measured: baseline, after week 5 (midpoint), after week 10 (immediate post)
Binge Eating
Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi)
Measured: baseline, after week 5 (midpoint), after week 10 (immediate post)
Intuitive Eating
Intuitive Eating Scale-2 (IES-2)
Measured: baseline, after week 5 (midpoint), after week 10 (immediate post)
Secondary outcomes (7)
Body Image
Body Image in Pregnancy Scale (BIPS)
Measured: baseline, after week 5 (midpoint), after week 10 (post-program)
General Well-being
General Well-being: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Measured: baseline, after week 5 (midpoint), after week 10 (post-program)
COVID-19-related Well-being
Perinatal COVID-19-related Well-being (COPE-IU)
Measured: baseline, after week 5 (midpoint), after week 10 (post-program)
Mindful Self-Care
Mindful Self-Care Scale (MSCS)
Measured: baseline, after week 5 (midpoint), after week 10 (immediate post)
Weight Bias Internalization
Weight Bias Internalization Scale-Modified (WBIS-M)
Measured: baseline, after week 5 (midpoint), after week 10 (immediate post)
Physical Activity
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Measured: baseline, after week 5 (midpoint), after week 10 (immediate post)
Depression
Edinburgh Postnatal Depression Scale (EPDS)
Measured: baseline, after week 5 (midpoint), after week 10 (immediate post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start11 Feb 2024
- Primary completion10 Mar 2024
- Study completion10 Mar 2024
Why it stopped: Insufficient enrollment - currently revisiting and updating study eligibility criteria - plan to shift the project to focus on the postpartum period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial of mindful eating self-help book (group 1) vs. mindful eating self-help book + companion smartphone app (group 2)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer B. Webb, Ph.D., University of North Carolina, Charlotte
- Investigators
- Jennifer B Webb, PhD, Principal investigator, UNC CharlotteV Gil-Rivas, PhD, Principal investigator, UNC Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581095
- Sponsor's protocol ID
- IRBIS-19-0680
- Status last verified
- May 2026
- First submitted
- 16 Jul 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05581095
- Acronym / sponsor ID
- IRBIS-19-0680
- Conditions
- Pregnancy, Binge Eating
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment - currently revisiting and updating study eligibility criteria - plan to shift the project to focus on the postpartum period
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Study start
- 11 Feb 2024 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 14 Oct 2022 (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.
Primary Study Aims:
- 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.
- 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.
- To gain insights into ways in which this program may be better tailored to the experiences of pregnancy for future program adaptation and refinement.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial of mindful eating self-help book (group 1) vs. mindful eating self-help book + companion smartphone app (group 2)
| Arm | Type | Receives |
|---|---|---|
| Mindful Eating Self-Help Book Only | Active comparator | Behavioral: Mindful Eating Self-Help ProgramParticipants 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. |
| Mindful Eating Self-Help Book + Smartphone App | Experimental | Behavioral: Mindful Eating Self-Help Program, Behavioral: Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Mindful Eating Self-Help Program10-week exposure to mindful eating principles and practices outlined in the Eat What You Love, Love What You Eat for Binge Eating book | Behavioural | Mindful Eating Self-Help Book + Smartphone App, Mindful Eating Self-Help Book Only |
| Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)10-week exposure to using a mindful eating mobile phone application daily. | Behavioural | Mindful Eating Self-Help Book + Smartphone App |
Primary outcome
Enrollment
Time frame: 6 months after opening enrollment
percent enrollment within 6 months of opening recruitment
Attrition
Time frame: throughout the 10-week program
percent of participants who dropped out
Program Satisfaction
Time frame: after week 10
participant satisfaction questionnaire
App Usability
Time frame: after week 10
app usability questionnaire
Mindful Eating
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Mindful Eating Inventory (MEI)
Binge Eating
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi)
Intuitive Eating
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Intuitive Eating Scale-2 (IES-2)
7 secondary outcomes
Body Image
Time frame: 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)
COVID-19-related Well-being
Time frame: 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)
Weight Bias Internalization
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Physical Activity
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Depression
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- 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.
Jennifer B Webb, PhD principal investigator
UNC Charlotte
V Gil-Rivas, PhD principal investigator
UNC Charlotte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating Self-Help Program and Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach) in people with Pregnancy and Binge Eating, run by University of North Carolina, Charlotte 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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 7 May 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Enrollment (time frame: 6 months after opening enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.