Pilot Testing a Novel Approach to Pediatric Obesity Treatment
Emotion Regulation Intervention to Improve Neural Responsiveness and Health
2 other identifiers
interventional
30
1 country
1
Brief Summary
The goal of this clinical trial is to learn if an emotion regulation and self-monitoring intervention can help treat overweight and obesity in teens. The main question it aims to answer is:
- Does emotion regulation and self-monitoring help reduce biases in teens with overweight and obesity?
- Do changes in biases relate to changes in health functioning and health behavior? Researchers will compare the intervention to the provision of educational handouts about overweight and obesity to see if the intervention is more effective. Participants will:
- Complete self-report questionnaires, an fMRI scan, and have their blood drawn
- Received educational handouts or attend weekly telehealth group sessions weekly for four weeks and be asked to self-monitor their mood and behavior between sessions
- Return to complete the same questionnaires, fMRI and blood draw procedures
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2026
1 active site
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
First Submitted
Initial submission to the registry
December 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 1, 2025
CompletedStudy Start
First participant enrolled
February 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 17, 2026
February 1, 2026
10 months
December 17, 2024
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
Used to index pre-post changes in neuronal responsiveness to obesity-related cues
From enrollment to the end of treatment at week 5
Glucose tolerance per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
From enrollment to the end of treatment at week 5
Triglycerides per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
From enrollment to the end of treatment at week 5
Cholesterol per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
From enrollment to the end of treatment at week 5
C peptide per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
From enrollment to the end of treatment at week 5
Emotion regulation per Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) and Positive Affect (DERS-PA) versions
Used to index pre-post changes in difficulties with positive and negative emotion regulation. Sum scores and average scores for each measure and subscale are used, with higher scores indicating greater difficulties with each domain
From enrollment to the end of treatment at week 5
Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-Questionnaire
Used to index pre-post changes in health behavior. Items are summed together and averaged, with higher scores indicating greater disordered eating cognitions and behaviors
From enrollment to the end of treatment at week 5
Self-report average daily minutes and intensity of physical activity per Patient-Reported Outcomes Measurement Information System (PROMIS) scale
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating greater frequency and intensity of physical activity
From enrollment to the end of treatment at week 5
Self-report average daily minutes and intensity of physical activity per Physical Activity Questionnaire for Adolescents (PAQ-A)
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating greater frequency and intensity of physical activity
From enrollment to the end of treatment at week 5
Self-report average daily minutes engaging in sedentary behavior per National Health and Nutrition Examination Survey (NHANES) items
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating more frequent sedentary behavior
From enrollment to the end of treatment at week 5
Self-report acceptability per face-valid questionnaire
Sum scored, with higher score indication higher acceptability
From enrollment to the end of treatment at week 5
Percentage of sessions attended (by participant)
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Number of participants enrolled
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Rate of attrition
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Study Arms (2)
Psychoeducation Control Group
ACTIVE COMPARATORParticipants assigned to the psychoeducation control group will receive informational handouts about overweight and obesity, including current daily sleep, diet, and physical activity recommendations to prevent/treat overweight and obesity.
Emotion Regulation and Self-Monitoring Program
EXPERIMENTALParticipants randomized to this condition will receive an active intervention which includes 4 weeks of an emotion regulation and self-monitoring program. Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.
Interventions
Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.
Participants who are randomized to the control group will receive an online, one-time, self-led psychoeducation program with information about current daily sleep, diet, and physical activity recommendations (e.g., information about sleep hygiene, the food pyramid, and recommendations for 60 minutes of moderate-to-vigorous physical activity daily).
Eligibility Criteria
You may qualify if:
- Being English-proficient
- Ages 11-14
- At or above the 85th BMI percentile based on age and sex norms
- Having access to WIFI or cellular data to attend the telehealth groups
- Living in a home in Lubbock County (TX) or surrounding areas.
You may not qualify if:
- Having a psychiatric or medical diagnosis that interferes with participation (e.g., significant developmental delay; pregnancy)
- Current enrollment in overweight/obesity treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech University
Lubbock, Texas, 79409, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 17, 2024
First Posted
January 1, 2025
Study Start
February 28, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
- Access Criteria
- Access to IPD will can be requested by qualified researchers following review and approval of a research proposal, confirmation of IRB approval, and execution of a Data Sharing Agreement. For more information or to submit a request, please contact Dr. Caroline Cummings at carolicu@ttu.edu
Deidentified participant data will be shared upon request and approval. To maintain privacy/confidentiality, fMRI scans and blood samples will not be shared, though specific values can be provided upon request.