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| ID | Type | Description | Link |
|---|---|---|---|
| U24DK132740 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Pennington Biomedical Research Center | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage BOLD (Blood Oxygenation Level Dependent) signal change | Used to index pre-post changes in neuronal responsiveness to obesity-related cues | 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 | 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 | 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 | 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 | 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 | From enrollment to the end of treatment at week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Cummings, PhD | Contact | 806-834-0931 | carolicu@ttu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University | Recruiting | Lubbock | Texas | 79409 | United States |
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.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
Access to IPD will can be requested by qualified researchers following review and approval of a research proposal, confirmation of IRB approval, and execution of a Data Sharing Agreement. For more information or to submit a request, please contact Dr. Caroline Cummings at carolicu@ttu.edu
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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). |
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| 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 |
| 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 | 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 | 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 | 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 | From enrollment to the end of treatment at week 5 |
| Percentage of sessions attended (by participant) | Used to index intervention feasibility | From enrollment to study completion, an average of 1 year |
| Number of participants enrolled | Used to index intervention feasibility | From enrollment to study completion, an average of 1 year |
| Rate of attrition | Used to index intervention feasibility | From enrollment to study completion, an average of 1 year |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |