An interventional study of Mindful Eating Self-Help Program and Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach) in Pregnancy and Binge Eating, sponsored by University of North Carolina, Charlotte. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by University of North Carolina, Charlotte · Not applicable, Interventional, and Treatment
Primary Study Aims:
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.
319 studies on the registry are indexed under Bulimia; 53 are open to participants now.
Browse Bulimia studies →University of North Carolina, Charlotte is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 · Behavioral: Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)
10-week exposure to mindful eating principles and practices outlined in the Eat What You Love, Love What You Eat for Binge Eating book
10-week exposure to using a mindful eating mobile phone application daily.
Enrollment
percent enrollment within 6 months of opening recruitment
Time frame: 6 months after opening enrollment
Attrition
percent of participants who dropped out
Time frame: throughout the 10-week program
Program Satisfaction
participant satisfaction questionnaire
Time frame: after week 10
App Usability
app usability questionnaire
Time frame: after week 10
Mindful Eating
Mindful Eating Inventory (MEI)
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Binge Eating
Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi)
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Intuitive Eating
Intuitive Eating Scale-2 (IES-2)
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Body Image
Body Image in Pregnancy Scale (BIPS)
Time frame: baseline, after week 5 (midpoint), after week 10 (post-program)
General Well-being
General Well-being: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: baseline, after week 5 (midpoint), after week 10 (post-program)
COVID-19-related Well-being
Perinatal COVID-19-related Well-being (COPE-IU)
Time frame: baseline, after week 5 (midpoint), after week 10 (post-program)
Mindful Self-Care
Mindful Self-Care Scale (MSCS)
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Weight Bias Internalization
Weight Bias Internalization Scale-Modified (WBIS-M)
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Physical Activity
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Depression
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: baseline, after week 5 (midpoint), after week 10 (immediate post)
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Charlotte