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Insufficient enrollment - currently revisiting and updating study eligibility criteria - plan to shift the project to focus on the postpartum period
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Eating Self-Help Program | Behavioral | 10-week exposure to mindful eating principles and practices outlined in the Eat What You Love, Love What You Eat for Binge Eating book |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment | percent enrollment within 6 months of opening recruitment | 6 months after opening enrollment |
| Attrition | percent of participants who dropped out | throughout the 10-week program |
| Program Satisfaction | participant satisfaction questionnaire | after week 10 |
| App Usability | app usability questionnaire | after week 10 |
| Mindful Eating | Mindful Eating Inventory (MEI) | baseline, after week 5 (midpoint), after week 10 (immediate post) |
| Binge Eating | Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi) | baseline, after week 5 (midpoint), after week 10 (immediate post) |
| Intuitive Eating | Intuitive Eating Scale-2 (IES-2) | baseline, after week 5 (midpoint), after week 10 (immediate post) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Image | Body Image in Pregnancy Scale (BIPS) | baseline, after week 5 (midpoint), after week 10 (post-program) |
| General Well-being | General Well-being: Warwick-Edinburgh Mental Well-being Scale (WEMWBS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer B Webb, PhD | UNC Charlotte | Principal Investigator |
| V Gil-Rivas, PhD | UNC Charlotte | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Charlotte | Charlotte | North Carolina | 28223 | United States |
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Randomized Controlled Trial of mindful eating self-help book (group 1) vs. mindful eating self-help book + companion smartphone app (group 2)
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| Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach) | Behavioral | 10-week exposure to using a mindful eating mobile phone application daily. |
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| baseline, after week 5 (midpoint), after week 10 (post-program) |
| COVID-19-related Well-being | Perinatal COVID-19-related Well-being (COPE-IU) | baseline, after week 5 (midpoint), after week 10 (post-program) |
| Mindful Self-Care | Mindful Self-Care Scale (MSCS) | baseline, after week 5 (midpoint), after week 10 (immediate post) |
| Weight Bias Internalization | Weight Bias Internalization Scale-Modified (WBIS-M) | baseline, after week 5 (midpoint), after week 10 (immediate post) |
| Physical Activity | International Physical Activity Questionnaire-Short Form (IPAQ-SF) | baseline, after week 5 (midpoint), after week 10 (immediate post) |
| Depression | Edinburgh Postnatal Depression Scale (EPDS) | baseline, after week 5 (midpoint), after week 10 (immediate post) |
| ID | Term |
|---|---|
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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