Clinical trial

Pilot Testing a Novel Approach to Pediatric Obesity Treatment

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT06755827

Recruiting nowPhase 1, Phase 2Interventional

What this study is 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age11 Years to 14 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight Adolescents, Obese Adolescents

Full registry 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)

Treatments and study arms

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).

Primary outcomes

Percentage BOLD (Blood Oxygenation Level Dependent) signal changeFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in neuronal responsiveness to obesity-related cues

Glucose tolerance per blood samplesFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in health indicators linked to overweight and obesity severity

Triglycerides per blood samplesFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in health indicators linked to overweight and obesity severity

Cholesterol per blood samplesFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in health indicators linked to overweight and obesity severity

C peptide per blood samplesFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in health indicators linked to overweight and obesity severity

Emotion regulation per Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) and Positive Affect (DERS-PA) versionsFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in difficulties with positive and negative emotion regulation. Sum scores and average scores for each measure and subscale are used, with higher scores indicating greater difficulties with each domain

Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-QuestionnaireFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in health behavior. Items are summed together and averaged, with higher scores indicating greater disordered eating cognitions and behaviors

Self-report average daily minutes and intensity of physical activity per Patient-Reported Outcomes Measurement Information System (PROMIS) scaleFrom enrollment to the end of treatment at week 5

Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating greater frequency and intensity of physical activity

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Texas Tech University🇺🇸 Lubbock, Texas, United States

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Caroline Cummings, PhDContact

Email · Call 806-834-0931