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

NCT05581095 | Withdrawn

• 1 other identifier: IRBIS-19-0680
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Study Aims:

1. 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. 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. 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.

Conditions

Pregnancy; Binge Eating

Outcome Measures

Primary Outcomes (7)

• 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)

Secondary Outcomes (7)

• Body Image

  baseline, after week 5 (midpoint), after week 10 (post-program)

• General Well-being

  baseline, after week 5 (midpoint), after week 10 (post-program)

• COVID-19-related Well-being

  baseline, after week 5 (midpoint), after week 10 (post-program)

• Mindful Self-Care

  baseline, after week 5 (midpoint), after week 10 (immediate post)

• Weight Bias Internalization

  baseline, after week 5 (midpoint), after week 10 (immediate post)

Study Arms (2)

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.

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.

Behavioral: Mindful Eating Self-Help Program; Behavioral: Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)

Interventions

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

Mindful Eating Self-Help Book + Smartphone App; Mindful Eating Self-Help Book Only

Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach) BEHAVIORAL

10-week exposure to using a mindful eating mobile phone application daily.

Mindful Eating Self-Help Book + Smartphone App

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Charlotte: lead

Study Sites (1)

UNC Charlotte

Charlotte, North Carolina, 28223, United States

Location

MeSH Terms

Conditions

Bulimia

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer B Webb, PhD

  UNC Charlotte

  PRINCIPAL INVESTIGATOR

• V Gil-Rivas, PhD

  UNC Charlotte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial of mindful eating self-help book (group 1) vs. mindful eating self-help book + companion smartphone app (group 2)

Study Record Dates

• First Submitted: July 16, 2022
• First Posted: October 14, 2022
• Study Start: February 11, 2024
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)