NCT06755827|RecruitingPhase 1/2
Pilot Testing a Novel Approach to Pediatric Obesity Treatment
Emotion Regulation Intervention to Improve Neural Responsiveness and Health
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Emotion Regulation Intervention to Improve Neural Responsiveness and Health
Sponsor study identifier
Secondary identifiers
NIH
interventional
30
1 country
1
Study Start
March 24, 2026
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 17, 2024
Actual (reported)January 1, 2025
Actual (reported)March 24, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
Used to index pre-post changes in neuronal responsiveness to obesity-related cues
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
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
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
From enrollment to the end of treatment at week 5
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.
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.
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).
Texas Tech University
Lubbock, Texas, 79409, United States
First Submitted
December 17, 2024
First Posted
January 1, 2025
Study Start
March 24, 2026
Actual (reported)Primary Completion
December 31, 2026
EstimatedHealthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats
C peptide per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
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
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
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
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
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
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
From enrollment to the end of treatment at week 5
Percentage of sessions attended (by participant)
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Number of participants enrolled
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Rate of attrition
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 15, 2026
Record last verified: 2026-05
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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