NCT04587752

Brief Summary

This study will perform a clinical trial with adolescents to pilot a new cognitive-behavioral treatment (CBT) for weight-related bullying testing (1) feasibility, (2) acceptability, and (3) initial efficacy. The treatment will be conducted via audio/video telehealth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 23, 2024

Completed
Last Updated

September 23, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

October 13, 2020

Results QC Date

August 29, 2024

Last Update Submit

August 29, 2024

Conditions

BullyingWeight, BodyTrauma, Psychological

Keywords

adolescentchildcognitive behavioral therapyeating disorderobesity

Outcome Measures

Primary Outcomes (1)

  • Stress

    Reductions in traumatic stress as measured by the Children's Revised Impact of Event Scale (total; scores range from 0 to 65 with higher scores indicative of more traumatic stress)

    post (3 months)

Secondary Outcomes (2)

  • Body Dissatisfaction

    post (3 months)

  • Overvaluation

    post (3 months)

Study Arms (1)

CBT for Weight Bullying

EXPERIMENTAL

Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying

Behavioral: CBT for Weight Bullying

Interventions

CBT for Weight BullyingBEHAVIORAL

Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.

CBT for Weight Bullying

Eligibility Criteria

Age11 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIdentifying as female
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Be in the age range ≥11 years old and ≤17 years old;
  • Report experiencing weight-related bullying
  • Report current distress about weight-related bullying
  • Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials;
  • Located in the United States and available for participation in the study for 3 months.

You may not qualify if:

  • Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., severe anorexia, neurological disorder, psychotic disorders, suicidality);
  • Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
  • Is pregnant or breastfeeding;
  • Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
  • Is engaged in concurrent treatments that focus on trauma-related stress;
  • Began taking hormonal contraceptives less than 3 months prior;
  • Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
  • Has avoidant/restrictive food intake disorder; or
  • Is participating in another clinical research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Lydecker JA, Ozbardakci EV, Lou R, Grilo CM. Trauma-Focused Cognitive-Behavioral Therapy for Adolescents Bullied Because of Weight: A Feasibility Study. Int J Eat Disord. 2024 Oct;57(10):2117-2127. doi: 10.1002/eat.24257. Epub 2024 Jul 15.

    PMID: 39007703DERIVED

MeSH Terms

Conditions

BullyingBody WeightPsychological TraumaFeeding and Eating DisordersObesity

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial BehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSigns and Symptoms, DigestiveOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Janet Lydecker
Organization
Yale University
janet.lydecker@yale.edu
2037374299

Study Officials

  • Janet A Lydecker, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 14, 2020

Study Start

October 5, 2020

Primary Completion

August 9, 2023

Study Completion

August 9, 2023

Last Updated

September 23, 2024

Results First Posted

September 23, 2024

Record last verified: 2024-08

Locations

US(1)