NCT06755827 · Texas Tech University
Pilot Testing a Novel Approach to Pediatric Obesity Treatment
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Emotion regulation and self-monitoring to treat pediatric obesity
Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.
OTHER
Psychoeducation
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).
Primary outcome measures
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in neuronal responsiveness to obesity-related cues
Glucose tolerance per blood samples
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Triglycerides per blood samples
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Cholesterol per blood samples
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in health indicators linked to overweight and obesity severity
C peptide per blood samples
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Emotion regulation per Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) and Positive Affect (DERS-PA) versions
Time frame: From enrollment to the end of treatment at week 5
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
Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-Questionnaire
Time frame: From enrollment to the end of treatment at week 5
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
Self-report average daily minutes and intensity of physical activity per Patient-Reported Outcomes Measurement Information System (PROMIS) scale
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating greater frequency and intensity of physical activity
Self-report average daily minutes and intensity of physical activity per Physical Activity Questionnaire for Adolescents (PAQ-A)
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating greater frequency and intensity of physical activity
Self-report average daily minutes engaging in sedentary behavior per National Health and Nutrition Examination Survey (NHANES) items
Time frame: From enrollment to the end of treatment at week 5
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating more frequent sedentary behavior
Self-report acceptability per face-valid questionnaire
Time frame: From enrollment to the end of treatment at week 5
Sum scored, with higher score indication higher acceptability
Percentage of sessions attended (by participant)
Time frame: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
Number of participants enrolled
Time frame: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
Rate of attrition
Time frame: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Being English-proficient
- 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.
Exclusion criteria
- Having a psychiatric or medical diagnosis that interferes with participation (e.g., significant developmental delay; pregnancy)
- Current enrollment in overweight/obesity treatment.
- Because the study will include entering an MRI scanner, additional standard exclusion criteria will be considered (e.g., having immovable medical devices with batteries, body piercings on the head/face, and having substantial visual impairment that cannot be corrected with staff-provided glasses)
Where
- Lubbock, Texas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pennington Biomedical Research Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations