Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention
Primary Purpose
Eating Disorders, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CoED Online Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders
Eligibility Criteria
Inclusion Criteria:
- young adults who have clinical or sub-clinical binge type ED, and comorbid overweight or obesity
Exclusion Criteria:
- adults under 18
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Intervention
Arm Description
Referral to standard care - student health center on campus.
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.
Outcomes
Primary Outcome Measures
Change in Eating Disorder Symptoms
Change in Eating Disorder Examination Questionnaire score
Change in Weight
Change in BMI
Secondary Outcome Measures
Full Information
NCT ID
NCT04248686
First Posted
January 23, 2020
Last Updated
July 6, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04248686
Brief Title
Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention
Official Title
Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Referral to standard care - student health center on campus.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CoED Online Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Eating Disorder Symptoms
Description
Change in Eating Disorder Examination Questionnaire score
Time Frame
baseline, 9-weeks, 6-months
Title
Change in Weight
Description
Change in BMI
Time Frame
baseline, 9-weeks, 6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
young adults who have clinical or sub-clinical binge type ED, and comorbid overweight or obesity
Exclusion Criteria:
adults under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise E Wilfley, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention
We'll reach out to this number within 24 hrs