Pilot Testing a Novel Approach to Pediatric Obesity Treatment

Phase 1

Not yet recruiting

• Conditions: Overweight Adolescents; Obese Adolescents

• Registration Number: NCT06755827
• Lead Sponsor: Texas Tech University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-24
• Study First Posted: 2025-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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