Clinical trial NCT06755827: Pilot Testing a Novel Approach to Pediatric Obesity Treatment
Official title: Emotion Regulation Intervention to Improve Neural Responsiveness and Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Overweight Adolescents
Obese Adolescents
Keywords: overweight
obesity
adolescents
neuronal responsiveness
emotion regulation
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Pennington Biomedical Research Center
First posted: 2025-01-01
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage BOLD (Blood Oxygenation Level Dependent) signal change
timeFrame: From enrollment to the end of treatment at week 5
measure: Glucose tolerance per blood samples
timeFrame: From enrollment to the end of treatment at week 5
measure: Triglycerides per blood samples
timeFrame: From enrollment to the end of treatment at week 5
measure: Cholesterol per blood samples
timeFrame: From enrollment to the end of treatment at week 5
measure: C peptide per blood samples
timeFrame: From enrollment to the end of treatment at week 5
measure: Emotion regulation per Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) and Positive Affect (DERS-PA) versions
timeFrame: From enrollment to the end of treatment at week 5
measure: Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-Questionnaire
timeFrame: From enrollment to the end of treatment at week 5
measure: Self-report average daily minutes and intensity of physical activity per Patient-Reported Outcomes Measurement Information System (PROMIS) scale
timeFrame: From enrollment to the end of treatment at week 5
measure: Self-report average daily minutes and intensity of physical activity per Physical Activity Questionnaire for Adolescents (PAQ-A)
timeFrame: From enrollment to the end of treatment at week 5
measure: Self-report average daily minutes engaging in sedentary behavior per National Health and Nutrition Examination Survey (NHANES) items
timeFrame: From enrollment to the end of treatment at week 5
measure: Self-report acceptability per face-valid questionnaire
timeFrame: From enrollment to the end of treatment at week 5
measure: Percentage of sessions attended (by participant)
timeFrame: From enrollment to study completion, an average of 1 year
measure: Number of participants enrolled
timeFrame: From enrollment to study completion, an average of 1 year
measure: Rate of attrition
timeFrame: From enrollment to study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: