Novel Executive Function Training for Obesity (NEXT)

University of California San Diego

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Novel Executive Function Training - NEXT; Behavioral: Behavioral Weight Loss - BWL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03724396

K23DK114480 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Novel Executive Function Training - NEXT

Experimental group

Description:

Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.

Treatment:

Behavioral: Novel Executive Function Training - NEXT

Behavioral: Behavioral Weight Loss - BWL

Behavioral Weight Loss - BWL

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss - BWL