Novel Executive Function Training for Obesity
- Conditions
- Overweight and Obesity
- Interventions
- Behavioral: Behavioral Weight Loss - BWLBehavioral: Novel Executive Function Training - NEXT
- Registration Number
- NCT03724396
- Lead Sponsor
- University of California, San Diego
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- Age 18-65
- Ability to read English at a 6th grade level
- BMI >25 and ≤45
- Difficulties with executive functioning
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Novel Executive Function Training - NEXT Behavioral Weight Loss - BWL Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills. Behavioral Weight Loss - BWL 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. Novel Executive Function Training - NEXT Novel Executive Function Training - NEXT Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.
- Primary Outcome Measures
Name Time Method Feasibility as Measured by Attendance Over the course of 6 months of treatment Number of Treatment Sessions Attended
Acceptability At 6 months Ratings of usefulness of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSD Center for Healthy Eating and Activity Research (CHEAR
🇺🇸La Jolla, California, United States