Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04248686 |
| Other study ID # |
201908221 - TL1TR002344 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2019 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
