Novel Executive Function Training for Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Feasibility as Measured by Attendance
研究概览
简要总结
Currently, the best behavioral treatments for obesity only work for 50% of adults, and of those who initially succeed, most do not maintain their weight loss. One reason for this failure may be due to neurocognitive deficits found among individuals with obesity, particularly related to executive function, which make it difficult for these adults to adhere to treatment recommendations. The proposed study aims to develop a Novel Executive Function Treatment (NEXT), which when administered prior to the behavioral treatment, could help improve outcomes by addressing the neurocognitive deficits in adults with overweight or obesity.
详细描述
First, to assist with treatment development, two groups of approximately 10 participants will be enrolled in a 12-week open-label treatment group of NEXT. These participants will then provide qualitative feedback to help with treatment development. After the two pilot groups, a randomized control trial will evaluate NEXT compared to standard BWL to assess feasibility, acceptability and preliminary efficacy. Treatment will be 6 months long and assessments will occur at baseline, mid-treatment, post-treatment and 6-months after treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Ability to read English at a 6th grade level
- •BMI >25 and ≤45
- •Difficulties with executive functioning
排除标准
- •Medical condition that requires physician monitoring to participate in weight control program or prohibits safely participating in recommended physical activity
- •Psychiatric condition that could interfere with program participant (e.g., substance abuse, suicide attempt within previous 6 months, active purging)
- •Currently pregnant, lactating or plan to be in the timespan of program follow-up
- •Current enrollment in an organized weight control program
- •Change in psychotropic medication or other medication that could have impact on weight during the previous 3 months
- •History of bariatric surgery
- •History of learning disorder, neurological condition or injury
结局指标
主要结局
Feasibility as Measured by Attendance
时间窗: Over the course of 6 months of treatment
Number of Treatment Sessions Attended
Acceptability
时间窗: At 6 months
Ratings of usefulness of treatment
次要结局
未报告次要终点
研究者
Dawn Eichen
Assistant Adjunct Professor
University of California, San Diego