Emotion Regulation Intervention to Improve Neural Responsiveness and Health
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage BOLD (Blood Oxygenation Level Dependent) signal change
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Emotion regulation and self-monitoring to treat pediatric obesity (Behavioral)
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.
干预措施: Psychoeducation (Other)
结局指标
主要结局
Percentage BOLD (Blood Oxygenation Level Dependent) signal change
时间窗: From 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 samples
时间窗: From 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 samples
时间窗: From 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 samples
时间窗: From 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 samples
时间窗: From 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) versions
时间窗: From 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-Questionnaire
时间窗: From 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) scale
时间窗: From 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
Self-report average daily minutes and intensity of physical activity per Physical Activity Questionnaire for Adolescents (PAQ-A)
时间窗: From 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
Self-report average daily minutes engaging in sedentary behavior per National Health and Nutrition Examination Survey (NHANES) items
时间窗: From 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 more frequent sedentary behavior
Self-report acceptability per face-valid questionnaire
时间窗: From enrollment to the end of treatment at week 5
Sum scored, with higher score indication higher acceptability
Percentage of sessions attended (by participant)
时间窗: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
Number of participants enrolled
时间窗: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
Rate of attrition
时间窗: From enrollment to study completion, an average of 1 year
Used to index intervention feasibility
次要结局
未报告次要终点
研究者
Caroline Cummings, PhD
Assistant Professor
Texas Tech University