IERCT: Intuitive Eating for Disordered Eating

Sponsor

Yeshiva University (Other)

Overall Status

Completed

CT.gov ID

NCT05031611

Collaborator

(none)

123

Enrollment

Location

Arms

11.3

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Eating Disorder Symptom Eating Behavior Body Image Psychological Distress	Behavioral: Intuitive Eating Treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 8, 2020

Actual Primary Completion Date :

Sep 2, 2020

Actual Study Completion Date :

Mar 17, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Intuitive Eating [Baseline (Time 1) through study completion, 10 weeks (Time 2)]
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 [Baseline (Time 1) through study completion, 10 weeks (Time 2)]
Revised Three Factor Eating Questionnaire (TFEQ-r18)

Secondary Outcome Measures

Body Appreciation [Baseline (Time 1) through study completion, 10 weeks (Time 2)]
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 [Baseline (Time 1) through study completion, 10 weeks (Time 2)]
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 [Baseline (Time 1) through study completion, 10 weeks (Time 2)]
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 [Baseline (Time 1) through study completion, 10 weeks (Time 2)]
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) [Baseline (Time 1) through study completion, 10 weeks (Time 2)]
Weight/Height used to calculate BMI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Study was conducted exclusively online	Bronx	New York	United States	10461

Sponsors and Collaborators

Yeshiva University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Yeshiva University

ClinicalTrials.gov Identifier:

NCT05031611

Other Study ID Numbers:

20200516

First Posted:

Sep 2, 2021

Last Update Posted:

Sep 2, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Feeding and Eating Disorders

Study Results

No Results Posted as of Sep 2, 2021