NCT05031611

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

July 14, 2021

Last Update Submit

August 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Body Appreciation

    Baseline (Time 1) through study completion, 10 weeks (Time 2)

  • Dichotomous Thinking Around Food

    Baseline (Time 1) through study completion, 10 weeks (Time 2)

  • Psychological Flexibility

    Baseline (Time 1) through study completion, 10 weeks (Time 2)

  • Food Intake

    Baseline (Time 1) through study completion, 10 weeks (Time 2)

  • Body Mass Index (BMI)

    Baseline (Time 1) through study completion, 10 weeks (Time 2)

Study Arms (2)

Intuitive Eating Treatment

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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.

Interventions

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.

Intuitive Eating Treatment

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen are affected by disordered eating at higher rates than men.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study was conducted exclusively online

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2021

First Posted

September 2, 2021

Study Start

April 8, 2020

Primary Completion

September 2, 2020

Study Completion

March 17, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Data will be made available upon request to jduncan1@mail.yu.edu

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Researchers may request data after investigators publish results

Locations