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

Primary Purpose

Pregnancy, Binge Eating

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Eating Self-Help Program
Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)
Sponsored by
University of North Carolina, Charlotte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UNC Charlotte

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mindful Eating Self-Help Book Only

Mindful Eating Self-Help Book + Smartphone App

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Enrollment
percent enrollment within 6 months of opening recruitment
Attrition
percent of participants who dropped out
Program Satisfaction
participant satisfaction questionnaire
App Usability
app usability questionnaire
Mindful Eating
Mindful Eating Inventory (MEI)
Binge Eating
Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi)
Intuitive Eating
Intuitive Eating Scale-2 (IES-2)

Secondary Outcome Measures

Body Image
Body Image in Pregnancy Scale (BIPS)
General Well-being
General Well-being: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
COVID-19-related Well-being
Perinatal COVID-19-related Well-being (COPE-IU)
Mindful Self-Care
Mindful Self-Care Scale (MSCS)
Weight Bias Internalization
Weight Bias Internalization Scale-Modified (WBIS-M)
Physical Activity
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Depression
Edinburgh Postnatal Depression Scale (EPDS)

Full Information

First Posted
July 16, 2022
Last Updated
May 19, 2023
Sponsor
University of North Carolina, Charlotte
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1. Study Identification

Unique Protocol Identification Number
NCT05581095
Brief Title
Empowering Mindfulness, Body Respect, and Compassionate Eating Among Women Who Binge Eat During Pregnancy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
We have experienced difficulty with recruitment and will be altering the study's eligibility criteria.
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Charlotte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Binge Eating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful Eating Self-Help Book Only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mindful Eating Self-Help Book + Smartphone App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Eating Self-Help Program
Intervention Description
10-week exposure to mindful eating principles and practices outlined in the Eat What You Love, Love What You Eat for Binge Eating book
Intervention Type
Behavioral
Intervention Name(s)
Mindful Eating Smartphone Application (Am I Hungry? Virtual Coach)
Intervention Description
10-week exposure to using a mindful eating mobile phone application daily.
Primary Outcome Measure Information:
Title
Enrollment
Description
percent enrollment within 6 months of opening recruitment
Time Frame
6 months after opening enrollment
Title
Attrition
Description
percent of participants who dropped out
Time Frame
throughout the 10-week program
Title
Program Satisfaction
Description
participant satisfaction questionnaire
Time Frame
after week 10
Title
App Usability
Description
app usability questionnaire
Time Frame
after week 10
Title
Mindful Eating
Description
Mindful Eating Inventory (MEI)
Time Frame
baseline, after week 5 (midpoint), after week 10 (immediate post)
Title
Binge Eating
Description
Eating Disorders Examination-Questionnaire with Instructions (EDE-Qi)
Time Frame
baseline, after week 5 (midpoint), after week 10 (immediate post)
Title
Intuitive Eating
Description
Intuitive Eating Scale-2 (IES-2)
Time Frame
baseline, after week 5 (midpoint), after week 10 (immediate post)
Secondary Outcome Measure Information:
Title
Body Image
Description
Body Image in Pregnancy Scale (BIPS)
Time Frame
baseline, after week 5 (midpoint), after week 10 (post-program)
Title
General Well-being
Description
General Well-being: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time Frame
baseline, after week 5 (midpoint), after week 10 (post-program)
Title
COVID-19-related Well-being
Description
Perinatal COVID-19-related Well-being (COPE-IU)
Time Frame
baseline, after week 5 (midpoint), after week 10 (post-program)
Title
Mindful Self-Care
Description
Mindful Self-Care Scale (MSCS)
Time Frame
baseline, after week 5 (midpoint), after week 10 (immediate post)
Title
Weight Bias Internalization
Description
Weight Bias Internalization Scale-Modified (WBIS-M)
Time Frame
baseline, after week 5 (midpoint), after week 10 (immediate post)
Title
Physical Activity
Description
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time Frame
baseline, after week 5 (midpoint), after week 10 (immediate post)
Title
Depression
Description
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame
baseline, after week 5 (midpoint), after week 10 (immediate post)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer B Webb, PhD
Organizational Affiliation
UNC Charlotte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
V Gil-Rivas, PhD
Organizational Affiliation
UNC Charlotte
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28223
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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