Intuitive Eating for Disordered Eating (IERCT)

A Web-based Intuitive Eating Intervention for Young Women With Disordered Eating: A Pilot Randomized Controlled Trial

Purpose: Research on intuitive eating is growing, but there are few interventions demonstrating the effect of learning to eat intuitively for people with disordered eating. Young women in particular are at high-risk for developing disordered eating. This study aimed to test the outcomes of a novel intuitive eating intervention for young women with disordered eating.

Methods: This study is the first randomized controlled trial introducing intuitive eating to a sample of participants with disordered eating. Participants with current eating disorders were excluded from this study. Women (n=123) ages 18-30 with high levels of disordered eating participated in this study and were randomized to either a treatment (10-week web-based intervention) or control group (10-week waitlist).

Study Overview

• Status: Completed
• Conditions: Psychological Distress; Body Image; Eating Behavior; Eating Disorder Symptom
• Intervention / Treatment: Behavioral: Intuitive Eating Treatment

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Study was conducted exclusively online

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Between 18 and 30 years of age
• Located in the United States or Canada
• No eating disorder
• No previous participation in an intuitive eating intervention
• Score greater than or equal to 25 on the TFEQ-r18 at baseline

Exclusion Criteria:

• Gender not female
• Younger than 18 years of age
• Older than 30 years of age
• Located outside the United States or Canada
• Score less than 25 on the TFEQ-r18 at baseline
• Previously participated in an intuitive eating intervention
• Current eating disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intuitive Eating Treatment; The intervention was a novel 10-week program aimed at promoting IE through pre-recorded videos, reading material, and bi-weekly discussion sessions. The intervention introduced the following modules sequentially: Unconditional Permission to Eat, Reliance to Hunger and Fullness Cues, Body-Food Choice Congruence, Gentle Nutrition, and Joyful Movement. Every other week, a new module was introduced. Participants were taught the concept of this module through video and reading, then prompted to practice it over the week. On opposite weeks, the module last introduced was discussed in greater detail through video, and participants were given the opportunity to discuss amongst one another and have all questions answered by the researchers.	Behavioral: Intuitive Eating Treatment; Participants received a brief web-based intervention for disordered eating which focused on a style of eating behavior called "intuitive eating". Please see arm description for more details.
No Intervention: Waitlist Control; Waitlist control group participants completed a series of questionnaires at the beginning and end of a 10-week interval, to compare changes in those who completed the intervention versus those who did not. This group was subsequently invited to participate in the intervention after their time on the wait-list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intuitive Eating	Intuitive eating was measured by the Intuitive Eating Scale, 2nd edition (IES-2). Scores on this scale range from 1 to 5, with higher scores indicating greater levels of Intuitive Eating.	Baseline (Time 1) through study completion, 10 weeks (Time 2)
Disordered Eating	Revised Three Factor Eating Questionnaire (TFEQ-r18)	Baseline (Time 1) through study completion, 10 weeks (Time 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Appreciation	Body appreciation was measured by the Body Appreciation Scale, 2nd edition (BAS-2). Scores on this scale range from 13 to 65, with higher scores indicating greater levels of body appreciation.	Baseline (Time 1) through study completion, 10 weeks (Time 2)
Dichotomous Thinking Around Food	Dichotomous thinking around food was measured by the Dichotomous Thinking Scale (DT). Scores on this scale range from 11 to 44, with higher scores indicating greater levels of dichotomous thinking around food.	Baseline (Time 1) through study completion, 10 weeks (Time 2)
Psychological Flexibility	Psychological flexibility was measured by the Acceptance and Action Questionnaire, 2nd edition (AAQ-2). Scores on this scale range from 7 to 49, with higher scores indicating greater psychological flexibility.	Baseline (Time 1) through study completion, 10 weeks (Time 2)
Food Intake	Food intake was measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data on respondents' food intake. Participants are asked to recall the frequency in which they consumed various food items over the past 3 days. Frequencies are grouped by food type (i.e., vegetables, fruits, dairy, etc.) and summed.	Baseline (Time 1) through study completion, 10 weeks (Time 2)
Body Mass Index (BMI)	Weight/Height used to calculate BMI	Baseline (Time 1) through study completion, 10 weeks (Time 2)

Collaborators and Investigators

• Sponsor: Yeshiva University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Actual): September 2, 2020
• Study Completion (Actual): March 17, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 20200516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request to jduncan1@mail.yu.edu
• IPD Sharing Time Frame: Researchers may request data after investigators publish results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No