Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention

NCT04248686 | Completed

• 1 other identifier: 201908221 - TL1TR002344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Eating Disorder Symptoms

  Change in Eating Disorder Examination Questionnaire score

  baseline, 9-weeks, 6-months

• Change in Weight

  Change in BMI

  baseline, 9-weeks, 6-months

Study Arms (2)

Control

NO INTERVENTION

Referral to standard care - student health center on campus.

Intervention

ACTIVE COMPARATOR

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.

Behavioral: CoED Online Intervention

Interventions

CoED Online Intervention BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• young adults who have clinical or sub-clinical binge type ED, and comorbid overweight or obesity

You may not qualify if:

• adults under 18

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Denise E Wilfley, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

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: January 23, 2020
• First Posted: January 30, 2020
• Study Start: December 13, 2019
• Primary Completion: August 25, 2021
• Study Completion: November 30, 2021
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)