Pilot Testing a Novel Approach to Pediatric Obesity Treatment
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age11-14
SponsorTexas Tech University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Emotion regulation and self-monitoring to treat pediatric obesity
BehavioralParticipants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.
Psychoeducation
Other interventionParticipants 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).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Psychoeducation Control GroupActive comparator 1 intervention
Group B: Emotion Regulation and Self-Monitoring ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
Used to index pre-post changes in neuronal responsiveness to obesity-related cues
Time frame
From enrollment to the end of treatment at week 52
Glucose tolerance per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Time frame
From enrollment to the end of treatment at week 53
Triglycerides per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Time frame
From enrollment to the end of treatment at week 54
Cholesterol per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Time frame
From enrollment to the end of treatment at week 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas Tech University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Pennington Biomedical Research Center
Collaborator
Source ClinicalTrials.gov