Eating Disorder SymptomIERCTNCT05031611
Intuitive Eating for Disordered Eating
A study testing Intuitive Eating Treatment in people with Eating Disorder Symptom and Eating Behavior, run by Yeshiva University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Eating Disorder Symptom, Eating Behavior, Body Image
- What is being tested?
- Intuitive Eating Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2020to 17 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Study was conducted exclusively online
The Bronx, New York, 10461
About this study
Official title: 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).
- Being tested
- Intuitive Eating Treatment
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intuitive Eating TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Disordered Eating
Revised Three Factor Eating Questionnaire (TFEQ-r18)
Measured: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Body Mass Index (BMI)
Weight/Height used to calculate BMI
Measured: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start8 Apr 2020
- Primary completion2 Sep 2020
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorder SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeshiva University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031611
- Sponsor's protocol ID
- 20200516
- Acronym
- IERCT
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request to jduncan1@mail.yu.edu
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Intuitive Eating Intervention for Young Women With Disordered Eating: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05031611
- Acronym / sponsor ID
- IERCT / 20200516
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Yeshiva UniversityUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intuitive Eating Treatment | Experimental | Behavioral: Intuitive Eating TreatmentThe 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 | 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intuitive Eating TreatmentParticipants 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. | Behavioural | Intuitive Eating Treatment |
Primary outcome
Intuitive Eating
Time frame: 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
Time frame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Revised Three Factor Eating Questionnaire (TFEQ-r18)
5 secondary outcomes
Body Appreciation
Time frame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Dichotomous Thinking Around Food
Time frame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Psychological Flexibility
Time frame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Food Intake
Time frame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Body Mass Index (BMI)
Time frame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Yes. Data will be made available upon request to jduncan1@mail.yu.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intuitive Eating Treatment in people with Eating Disorder Symptom and Eating Behavior, run by Yeshiva University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intuitive Eating (time frame: Baseline (Time 1) through study completion, 10 weeks (Time 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.