A Phase 1/2 interventional study of Emotion regulation and self-monitoring to treat pediatric obesity and Psychoeducation in Overweight Adolescents and Obese Adolescents, sponsored by Texas Tech University. Recruiting at 1 site in United States. Open to participants aged 11 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Texas Tech University · Phase 1/2, Interventional, and Treatment
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:
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:
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Texas Tech University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Other: Psychoeducation
Participants 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.
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.
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).
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
Used to index pre-post changes in neuronal responsiveness to obesity-related cues
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at week 5
Percentage of sessions attended (by participant)
Used to index intervention feasibility
Time frame: From enrollment to study completion, an average of 1 year
Number of participants enrolled
Used to index intervention feasibility
Time frame: From enrollment to study completion, an average of 1 year
Rate of attrition
Used to index intervention feasibility
Time frame: From enrollment to study completion, an average of 1 year
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, 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
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 39 non-industry phase 1/2 interventional studies under Obesity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 36. This study's planned 9 months is below that.
Counting every sponsor, half of 62 studies reached it within 27 months; a quarter within 14 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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