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
- 1
- 主要终点
- Acceptability
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
研究组 & 干预措施
Novel Executive Function Training - NEXT
Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.
干预措施: Behavioral Weight Loss - BWL (Behavioral)
Novel Executive Function Training - NEXT
Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.
干预措施: Novel Executive Function Training - NEXT (Behavioral)
Behavioral Weight Loss - BWL
All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories (with a calorie counter provided or on their phone), and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.
干预措施: Behavioral Weight Loss - BWL (Behavioral)
结局指标
主要结局
Acceptability
时间窗: At 6 months
Ratings of usefulness of treatment
Feasibility as Measured by Attendance
时间窗: Over the course of 6 months of treatment
Number of Treatment Sessions Attended
次要结局
未报告次要终点
研究者
Dawn Eichen
Assistant Adjunct Professor
University of California, San Diego