Pilot Testing a Novel Approach to Pediatric Obesity Treatment

May 13, 2026 updated by: Caroline Cummings, PhD, Texas Tech University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
Time Frame: From enrollment to the end of treatment at week 5
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
Time Frame: 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
From enrollment to the end of treatment at week 5
Triglycerides per blood samples
Time Frame: 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
From enrollment to the end of treatment at week 5
Cholesterol per blood samples
Time Frame: 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
From enrollment to the end of treatment at week 5
C peptide per blood samples
Time Frame: 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
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
Time Frame: 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
From enrollment to the end of treatment at week 5
Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-Questionnaire
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
From enrollment to the end of treatment at week 5
Self-report acceptability per face-valid questionnaire
Time Frame: From enrollment to the end of treatment at week 5
Sum scored, with higher score indication higher acceptability
From enrollment to the end of treatment at week 5
Percentage of sessions attended (by participant)
Time Frame: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Number of participants enrolled
Time Frame: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year
Rate of attrition
Time Frame: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
From enrollment to study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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