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Recruiting NCT06755827

Pilot Testing a Novel Approach to Pediatric Obesity Treatment

Phase I / Phase II Interventional Overweight Adolescents Obese Adolescents

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emotion regulation and self-monitoring to treat pediatric obesity, Psychoeducation.
Who it may be relevant to
Registry conditions: Overweight Adolescents, Obese Adolescents. Basic parameters: 11 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Emotion Regulation Intervention to Improve Neural Responsiveness and Health

Overview

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

Interventions

  • 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.
  • 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).

Primary outcome measures

  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Texas Tech University — Lubbock

Identifiers

NCT: NCT06755827 · 25-0493 · U24DK132740

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗