- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04248686
Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention
July 6, 2022 updated by: Washington University School of Medicine
Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention Pilot Study
Online, guided self-help interventions have been used for weight-loss (WL), as well as for treatment of eating disorders (EDs), separately, but no program exists to manage these conditions together.
To date, a combination ED and WL intervention has been piloted in adolescents who endorsed high-risk ED behavior and had overweight, and revealed moderate improvement in ED behavior and WL.
Thus, the use of online intervention for ED psychopathology and WL in individuals with clinical and sub-clinical EDs is the next step.
Given Dr. Wilfley's past expertise with ED and WL interventions, and particularly her involvement with online interventions for these issues her mentorship will support the carrying out of aims for this proposal.
The goal of this proposal is to implement a program to reduce weight and shape concerns, reduce disordered eating symptoms such as binging and compensatory behaviors associated with binge-type EDs, while also reducing weight for college students with comorbid overweight/obesity.
This project will pilot an online, guided self-help ED intervention that offers cognitive behavioral therapy (CBT) based tools to improve ED symptoms, while also teaching them healthy methods of behavioral WL, for individuals with clinical/sub-clinical binge-type EDs with comorbid overweight/obesity in order to examine effectiveness compared to referral to Student Health Services for ED and WL concerns.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The intersection of eating disorders and overweight/obesity reveals a large, and mostly underserved, population.
Having overweight/obesity as a child is a risk factor for an ED, as many adolescents with overweight/obesity utilize disordered eating methods in order to lose weight.
Conversely, binge-type EDs increase risk for overweight/obesity as binge episodes can lead to further weight gain.
Additionally, treatment of overweight early is especially important as individuals with overweight have an increased likelihood of moving from overweight to obesity status.
Despite this intertwined problem, few interventions exist that address ED pathology combined with a healthy weight loss (WL) intervention.
A particular population in need of intervention for EDs with comorbid overweight/obesity is the college student population.
Intervention at the college level is important as it is also prevention for future complications of EDs and overweight/obesity.
Combined intervention for EDs and overweight for young adults, specifically college students, is needed programming which could potentially have substantial long-term health benefits.
This project will pilot an online, guided self-help ED intervention that offers cognitive behavioral therapy based tools to improve ED symptoms while also teaching the healthy WL methods and maintenance of behavioral WL for individuals with clinical/sub-clinical binge-type EDs with comorbid overweight/obesity.
Participants will take the online screen by going to the URL address listed on the study advertisement.
Before answering any survey questions, they will read a consent information sheet on the study, and consent to having their information stored so that they can be reached later if eligible for the long term study.
They will then complete screening questions asking about their eating habits and weight and shape concerns.
Lastly, they will be asked if they are interested in taking part in the long term study, and if so, at what email address would they like to be reached.
Eligible criteria include endorsing clinical/sub-clinical symptoms of a binge-type ED, having a BMI > 25, and wanting to lose weight.
If an individual screens positive for having low weight, as characterized by a BMI < 18.5, they will automatically be provided a referral to student health services at the end of their survey.
Those that are eligible to participate will be sent emails to ask if they are interested in participating in this study.
If they are interested, they will come into the lab to read and sign consent information.
To minimize coercion, they will have as much time as they like to read and consider participation.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- young adults who have clinical or sub-clinical binge type ED, and comorbid overweight or obesity
Exclusion Criteria:
- adults under 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Referral to standard care - student health center on campus.
|
|
Active Comparator: Intervention
Online, guided self-help ED intervention that offers cognitive behavioral therapy (CBT) based tools to improve ED symptoms, while also teaching the healthy methods of behavioral WL, for individuals with clinical/sub-clinical binge-type EDs with comorbid overweight/obesity.
|
Online, guided self-help ED intervention that offers cognitive behavioral therapy (CBT) based tools to improve ED symptoms, while also teaching the healthy methods of behavioral WL, for individuals with clinical/sub-clinical binge-type EDs with comorbid overweight/obesity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Eating Disorder Symptoms
Time Frame: baseline, 9-weeks, 6-months
|
Change in Eating Disorder Examination Questionnaire score
|
baseline, 9-weeks, 6-months
|
Change in Weight
Time Frame: baseline, 9-weeks, 6-months
|
Change in BMI
|
baseline, 9-weeks, 6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Denise E Wilfley, Ph.D., Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2019
Primary Completion (Actual)
August 25, 2021
Study Completion (Actual)
November 30, 2021
Study Registration Dates
First Submitted
January 23, 2020
First Submitted That Met QC Criteria
January 28, 2020
First Posted (Actual)
January 30, 2020
Study Record Updates
Last Update Posted (Actual)
July 7, 2022
Last Update Submitted That Met QC Criteria
July 6, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201908221 - TL1TR002344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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