Pilot Testing a Novel Approach to Pediatric Obesity Treatment
NCT ID: NCT06755827
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2025-12-01
2025-12-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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 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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Current enrollment in overweight/obesity treatment.
11 Years
14 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Pennington Biomedical Research Center
OTHER
Texas Tech University
OTHER
Responsible Party
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Caroline Cummings, PhD
Assistant Professor
Central Contacts
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Other Identifiers
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25-0493
Identifier Type: -
Identifier Source: org_study_id