Clinical trial NCT03724396: Novel Executive Function Training for Obesity
Official title: Novel Executive Function Training for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: weight loss
executive function
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-10-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as Measured by Attendance
timeFrame: Over the course of 6 months of treatment
measure: Acceptability
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
measure: BMI Change
timeFrame: From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)
measure: Executive Function
timeFrame: From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR
state: California
Study officials:
affiliation: UC San Diego
name: Dawn Eichen, PhD
role: PRINCIPAL_INVESTIGATOR
References: