Novel Executive Function Training for Obesity (NEXT)

• ClinicalTrials.gov Identifier: NCT03724396
• Recruitment Status: Recruiting
• First Posted: October 30, 2018
• Last Update Posted: August 3, 2021
• Sponsor: University of California, San Diego
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Dawn Eichen, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight and Obesity	Behavioral: Behavioral Weight Loss - BWL; Behavioral: Novel Executive Function Training - NEXT	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Novel Executive Function Training for Obesity
• Actual Study Start Date: June 5, 2019
• Estimated Primary Completion Date: May 31, 2023
• Estimated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Novel Executive Function Training - NEXT; Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.	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.; Behavioral: 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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility as measured by number of treatment sessions attendned [ Time Frame: Over the course of 6 months of treatment ]
   Attendance at Treatment Sessions
2. Acceptability [ Time Frame: At 6 months ]
   Ratings of usefulness of treatment

Other Outcome Measures:

1. BMI Change [ Time Frame: Through study completion, an average of 12 months ]
   change in BMI (kg/m2)
2. Executive Function [ Time Frame: Through study completion, an average of 12 months ]
   Change in executive function measured by BRIEF

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Allison Tietz, BS; 858-380-5579; astietz@health.ucsd.edu

Contact: Dawn Eichen, PhD; 858-534-8322; deichen@health.ucsd.edu

Locations

United States, California

UCSD Center for Healthy Eating and Activity Research (CHEAR; Recruiting

La Jolla, California, United States, 92093

Contact: Allison Tietz, BS 858-380-5579 astietz@health.ucsd.edu

Principal Investigator: Dawn Eichen

Sponsors and Collaborators

University of California, San Diego

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Dawn Eichen, PhD; UC San Diego

More Information

• Responsible Party: Dawn Eichen, Assistant Adjunct Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03724396
• Other Study ID Numbers: K23DK114480 ( U.S. NIH Grant/Contract ); K23DK114480 ( U.S. NIH Grant/Contract )
• First Posted: October 30, 2018
• Last Update Posted: August 3, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn Eichen, University of California, San Diego:

weight loss; executive function

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight