Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06755827

Pilot Testing a Novel Approach to Pediatric Obesity Treatment

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Overweight Adolescents Behavior Body Weight Emotional Regulation Nutrition Disorders Nutritional and Metabolic Diseases Obese Adolescents Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Social Behavior

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Texas Tech University

Lubbock, Texas, 79409, United States

Location status: Recruiting

Location contact

Caroline Cummings, PhD

CONTACT

[email protected]

806-834-0931

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Emotion regulation and self-monitoring to treat pediatric obesity

Behavioral

Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.

Psychoeducation

Other

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Percentage of sessions attended (by participant)

    Time frame: From enrollment to study completion, an average of 1 year

    Used to index intervention feasibility

  13. Number of participants enrolled

    Time frame: From enrollment to study completion, an average of 1 year

    Used to index intervention feasibility

  14. Rate of attrition

    Time frame: From enrollment to study completion, an average of 1 year

    Used to index intervention feasibility

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Cummings, PhD

CONTACT

[email protected]

806-834-0931

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Pennington Biomedical Research Center

Registry information

Official study title

Emotion Regulation Intervention to Improve Neural Responsiveness and Health

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.