Pilot Testing a Novel Approach to Pediatric Obesity Treatment

Part of paid clinical trials in Lubbock, Texas.

Sponsor
Texas Tech University
Study ID
NCT06755827
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obese Adolescents
  • Overweight Adolescents

Eligibility Criteria

Sex
ALL
Age
11 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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

Key Dates

Start date
Mar 24, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Percentage BOLD (Blood Oxygenation Level Dependent) signal change [ Time Frame: From enrollment to the end of treatment at week 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Tech UniversityLubbockTexas79409
Caroline Cummings, PhD
[email protected]
806-834-0931

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By research site
Texas Tech University· Lubbock, TX

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