Novel Executive Function Training for Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Executive Function Training for Obesity

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Behavioral Weight Loss - BWL
* Behavioral: Novel Executive Function Training - NEXT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Ability to read English at a 6th grade level BMI >25 and ≤45 Difficulties with executive functioning Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel Executive Function Training - NEXT<br>Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills. | Behavioral: Behavioral Weight Loss - BWL<br>* 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.<br>Behavioral: Novel Executive Function Training - NEXT<br>* Modifies programs like CogSMART and cognitive remediation training to help participants improve executive functioning to adhere to recommendations from BWL.<br>|
| Active Comparator: Behavioral Weight Loss - BWL<br>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. | Behavioral: Behavioral Weight Loss - BWL<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by number of treatment sessions attendned | Attendance at Treatment Sessions | Over the course of 6 months of treatment | 
| Acceptability | Ratings of usefulness of treatment | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, executive function