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Intuitive Eating for Disordered Eating (IERCT)

Primary Purpose

Eating Disorder Symptom, Eating Behavior, Body Image

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intuitive Eating Treatment
Sponsored by
Yeshiva University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder Symptom

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Study was conducted exclusively online

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intuitive Eating Treatment

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Disordered Eating
Revised Three Factor Eating Questionnaire (TFEQ-r18)

Secondary Outcome Measures

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.
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.
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.
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.
Body Mass Index (BMI)
Weight/Height used to calculate BMI

Full Information

First Posted
July 14, 2021
Last Updated
August 26, 2021
Sponsor
Yeshiva University
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1. Study Identification

Unique Protocol Identification Number
NCT05031611
Brief Title
Intuitive Eating for Disordered Eating
Acronym
IERCT
Official Title
A Web-based Intuitive Eating Intervention for Young Women With Disordered Eating: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
March 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeshiva University

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder Symptom, Eating Behavior, Body Image, Psychological Distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intuitive Eating Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intuitive Eating Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intuitive Eating
Description
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.
Time Frame
Baseline (Time 1) through study completion, 10 weeks (Time 2)
Title
Disordered Eating
Description
Revised Three Factor Eating Questionnaire (TFEQ-r18)
Time Frame
Baseline (Time 1) through study completion, 10 weeks (Time 2)
Secondary Outcome Measure Information:
Title
Body Appreciation
Description
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.
Time Frame
Baseline (Time 1) through study completion, 10 weeks (Time 2)
Title
Dichotomous Thinking Around Food
Description
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.
Time Frame
Baseline (Time 1) through study completion, 10 weeks (Time 2)
Title
Psychological Flexibility
Description
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.
Time Frame
Baseline (Time 1) through study completion, 10 weeks (Time 2)
Title
Food Intake
Description
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.
Time Frame
Baseline (Time 1) through study completion, 10 weeks (Time 2)
Title
Body Mass Index (BMI)
Description
Weight/Height used to calculate BMI
Time Frame
Baseline (Time 1) through study completion, 10 weeks (Time 2)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women are affected by disordered eating at higher rates than men.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Study was conducted exclusively online
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Intuitive Eating for Disordered Eating

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