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

Withdrawn before enrolling · Not applicable

Conditions studied: Pregnancy, Binge Eating

In brief

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.

Key facts

Study ID

NCT05581095

Run by

University of North Carolina, Charlotte

People needed

0

Starts

2024-02-11

Expected to finish

2024-03-10

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• UNC Charlotte — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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