Novel Executive Function Training for Obesity

Overweight and Obesity Clinical Trial

— NEXT  

Official title:

Novel Executive Function Training for Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724396
• Other study ID #: K23DK114480
• Secondary ID: K23DK114480
• Status: Completed
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: January 14, 2023

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 14, 2023
• Est. primary completion date: January 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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.
• Novel Executive Function Training - NEXT
Modifies programs like CogSMART and cognitive remediation training to help participants improve executive functioning to adhere to recommendations from BWL.

Locations

Country	Name	City	State
United States	UCSD Center for Healthy Eating and Activity Research (CHEAR	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI Change	change in BMI (kg/m2)	From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)
Other	Executive Function	Change in executive function measured by Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) Global Executive Composite T score which reflects overall levels of executive dysfunction; T-scores have a mean of 50 and a standard deviation of 10. Higher T-scores mean greater executive dysfunction or lower/poorer executive function. T-scores at or greater than 65 are considered clinically significant measure of executive dysfunction.	From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)
Primary	Feasibility as Measured by Attendance	Number of Treatment Sessions Attended	Over the course of 6 months of treatment
Primary	Acceptability	Ratings of usefulness of treatment	At 6 months