Recruiting
Phase 1
Phase 2

Emotion Regulation

Sponsor:

Texas Tech University

Code:

NCT06755827

Conditions

Overweight Adolescents

Obese Adolescents

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

Interventions

Emotion regulation and self-monitoring to treat pediatric obesity

Psychoeducation

Study Details

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

Conditions

Overweight Adolescents

Obese Adolescents

Study ID

NCT06755827

Start date

Mar 24, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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).

Primary outcome measure

  • Percentage BOLD (Blood Oxygenation Level Dependent) signal change [ Time Frame: 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 ]
  • Triglycerides per blood samples [ Time Frame: 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 ]
  • C peptide per blood samples [ Time Frame: 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 ]
  • Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-Questionnaire [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Self-report acceptability per face-valid questionnaire [ Time Frame: 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 ]
  • Number of participants enrolled [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Caroline Cummings, PhD

806-834-0931carolicu@ttu.edu

Locations

Texas Tech University

Recruiting

Lubbock, Texas, United States, 79409

Contacts

Caroline Cummings, PhD

806-834-0931carolicu@ttu.edu

More Information

Sponsor

Texas Tech University

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • overweight
  • obesity
  • adolescents
  • neuronal responsiveness
  • emotion regulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Tech University on 2026-05-15.