Overweight AdolescentsPhase 1/2NCT06755827
Pilot Testing a Novel Approach to Pediatric Obesity Treatment
A Phase 1/2 study testing Emotion regulation and self-monitoring to treat pediatric obesity and Psychoeducation in people with Overweight Adolescents and Obese Adolescents, run by Texas Tech University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Overweight Adolescents, Obese Adolescents
- What is being tested?
- Emotion regulation and self-monitoring to treat pediatric obesity and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 31 Dec 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University
Lubbock, Texas, 79409
Caroline Cummings, PhD, 806-834-0931, carolicu@ttu.edu
About this study
Official title: Emotion Regulation Intervention to Improve Neural Responsiveness and Health
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?
Read more
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
- Conditions
- Overweight Adolescents, Obese Adolescents
- Being tested
- Emotion regulation and self-monitoring to treat pediatric obesity, Psychoeducation
- Keywords
- overweight, obesity, adolescents, neuronal responsiveness, emotion regulation
- Medical subject headings
- Overweight, Obesity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion regulation and self-monitoring to treat pediatric obesityBehavioural
Participants will attend telehealth group sessions once weekly and be asked to self-monitor their mood and health behaviors daily between sessions.
PsychoeducationOther
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 group | Role | What they receive |
|---|---|---|
| Psychoeducation Control Group | Active comparator | 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. Receives: Other: Psychoeducation |
| Emotion Regulation and Self-Monitoring Program | Experimental | 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. Receives: Behavioral: Emotion regulation and self-monitoring to treat pediatric obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
Used to index pre-post changes in neuronal responsiveness to obesity-related cues
Measured: From enrollment to the end of treatment at week 5
Glucose tolerance per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Measured: From enrollment to the end of treatment at week 5
Triglycerides per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Measured: From enrollment to the end of treatment at week 5
Cholesterol per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Measured: From enrollment to the end of treatment at week 5
C peptide per blood samples
Used to index pre-post changes in health indicators linked to overweight and obesity severity
Measured: From enrollment to the end of treatment at week 5
Emotion regulation per Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) and Positive Affect (DERS-PA) versions
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
Measured: From enrollment to the end of treatment at week 5
Self-report disordered eating cognitions and behaviors per Eating Disorder Examination-Questionnaire
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
Measured: From enrollment to the end of treatment at week 5
Self-report average daily minutes and intensity of physical activity per Patient-Reported Outcomes Measurement Information System (PROMIS) scale
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating greater frequency and intensity of physical activity
Measured: From enrollment to the end of treatment at week 5
Self-report average daily minutes and intensity of physical activity per Physical Activity Questionnaire for Adolescents (PAQ-A)
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating greater frequency and intensity of physical activity
Measured: From enrollment to the end of treatment at week 5
Self-report average daily minutes engaging in sedentary behavior per National Health and Nutrition Examination Survey (NHANES) items
Used to index pre-post changes in health behavior. Items are summed together with higher scores indicating more frequent sedentary behavior
Measured: From enrollment to the end of treatment at week 5
Self-report acceptability per face-valid questionnaire
Sum scored, with higher score indication higher acceptability
Measured: From enrollment to the end of treatment at week 5
Percentage of sessions attended (by participant)
Used to index intervention feasibility
Measured: From enrollment to study completion, an average of 1 year
Number of participants enrolled
Used to index intervention feasibility
Measured: From enrollment to study completion, an average of 1 year
Rate of attrition
Used to index intervention feasibility
Measured: From enrollment to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start24 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Caroline Cummings, PhD, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755827
- Sponsor's protocol ID
- 25-0493
- Other IDs
- U24DK132740
- Status last verified
- May 2026
- First submitted
- 17 Dec 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be shared upon request and approval. To maintain privacy/confidentiality, fMRI scans and blood samples will not be shared, though specific values can be provided upon request.