Emotion Regulation Intervention to Improve Neural Responsiveness and Health
| Registry | NCT06755827 |
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| Status | Recruiting |
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| Phase | Phase 1 / Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 30 (Estimated) |
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| Sponsor | Texas Tech University (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pennington Biomedical Research Center |
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| Conditions | Overweight Adolescents, Obese Adolescents |
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| Interventions | Emotion regulation and self-monitoring to treat pediatric obesity, Psychoeducation (Behavioral, other) |
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| Dates | start 2026-03-24, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-01-01, last updated 2026-05-15 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Overweight Adolescents All trials for Obese Adolescents All trials of Emotion regulation and self-monitoring to treat pediatric obesity All trials of Psychoeducation
-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
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Psychoeducation Control Group | Active comparator | Other: Psychoeducation | 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. |
| Emotion Regulation and Self-Monitoring Program | Experimental | Behavioral: Emotion regulation and self-monitoring to treat pediatric obesity | 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. |
- Emotion regulation and self-monitoring to treat pediatric obesity (Behavioral): Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.
- Psychoeducation (Other): 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).
+Outcome measures
Primary outcomes
- Percentage BOLD (Blood Oxygenation Level Dependent) signal change [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 [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 [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 [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 [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 [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 [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 [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) [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 [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 [From enrollment to the end of treatment at week 5]: Sum scored, with higher score indication higher acceptability
- Percentage of sessions attended (by participant) [From enrollment to study completion, an average of 1 year]: Used to index intervention feasibility
- Number of participants enrolled [From enrollment to study completion, an average of 1 year]: Used to index intervention feasibility
- Rate of attrition [From enrollment to study completion, an average of 1 year]: Used to index intervention feasibility
+Eligibility
Sex: All, ages: 11 Years to 14 Years
Inclusion Criteria:
* 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.
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)
+Locations (1)
| Facility | City | Country | Status |
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| Texas Tech University | Lubbock, Texas | United States | Recruiting |
+Funding