Pilot Testing a Novel Approach to Pediatric Obesity Treatment

Texas Tech University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Overweight Adolescents; Obese Adolescents

Treatments: Other: Psychoeducation; Behavioral: Emotion regulation and self-monitoring to treat pediatric obesity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06755827

25-0493

U24DK132740 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Psychoeducation Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Psychoeducation

Emotion Regulation and Self-Monitoring Program

Experimental group

Description:

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.

Treatment:

Behavioral: Emotion regulation and self-monitoring to treat pediatric obesity