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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05581095
• Other study ID #: IRBIS-19-0680
• Status: Suspended
• Phase: N/A
• Start date: August 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: University of North Carolina, Charlotte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Bulimia
• Pregnancy

Intervention

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
• Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)
10-week exposure to using a mindful eating mobile phone application daily.

Locations

Country	Name	City	State
United States	UNC Charlotte	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	percent enrollment within 6 months of opening recruitment	6 months after opening enrollment
Primary	Attrition	percent of participants who dropped out	throughout the 10-week program
Primary	Program Satisfaction	participant satisfaction questionnaire	after week 10
Primary	App Usability	app usability questionnaire	after week 10
Primary	Mindful Eating	Mindful Eating Inventory (MEI)	baseline, after week 5 (midpoint), after week 10 (immediate post)
Primary	Binge Eating	Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi)	baseline, after week 5 (midpoint), after week 10 (immediate post)
Primary	Intuitive Eating	Intuitive Eating Scale-2 (IES-2)	baseline, after week 5 (midpoint), after week 10 (immediate post)
Secondary	Body Image	Body Image in Pregnancy Scale (BIPS)	baseline, after week 5 (midpoint), after week 10 (post-program)
Secondary	General Well-being	General Well-being: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)	baseline, after week 5 (midpoint), after week 10 (post-program)
Secondary	COVID-19-related Well-being	Perinatal COVID-19-related Well-being (COPE-IU)	baseline, after week 5 (midpoint), after week 10 (post-program)
Secondary	Mindful Self-Care	Mindful Self-Care Scale (MSCS)	baseline, after week 5 (midpoint), after week 10 (immediate post)
Secondary	Weight Bias Internalization	Weight Bias Internalization Scale-Modified (WBIS-M)	baseline, after week 5 (midpoint), after week 10 (immediate post)
Secondary	Physical Activity	International Physical Activity Questionnaire-Short Form (IPAQ-SF)	baseline, after week 5 (midpoint), after week 10 (immediate post)
Secondary	Depression	Edinburgh Postnatal Depression Scale (EPDS)	baseline, after week 5 (midpoint), after week 10 (immediate post)