Pilot Testing a Novel Approach to Pediatric Obesity Treatment

Emotion Regulation Intervention to Improve Neural Responsiveness and Health

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

Study Overview

• Status: Recruiting
• Conditions: Overweight Adolescents; Obese Adolescents
• Intervention / Treatment: Other: Psychoeducation; Behavioral: Emotion regulation and self-monitoring to treat pediatric obesity

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Caroline Cummings, PhD; Phone Number: 806-834-0931; Email: carolicu@ttu.edu

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79409
      • Recruiting
      • Texas Tech University
      • Contact: Caroline Cummings, PhD; Phone Number: 806-834-0931; Email: carolicu@ttu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychoeducation Control Group; 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 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).
Experimental: Emotion Regulation and Self-Monitoring Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Texas Tech University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): January 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: obesity; overweight; adolescents; emotion regulation; neuronal responsiveness
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Social Behavior; Self-Control; Overweight; Obesity; Emotional Regulation
• Other Study ID Numbers: 25-0493; U24DK132740 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No