Novel Executive Function Training for Obesity

NCT03724396 | Completed Results DMC

• 1 other identifier: K23DK114480
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

weight loss; executive function

Outcome Measures

Primary Outcomes (2)

• Feasibility as Measured by Attendance

  Number of Treatment Sessions Attended

  Over the course of 6 months of treatment

• Acceptability

  Ratings of usefulness of treatment

  At 6 months

Other Outcomes (2)

• BMI Change

  From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)

• Executive Function

  From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)

Study Arms (2)

Novel Executive Function Training - NEXT

EXPERIMENTAL

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

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

Behavioral Weight Loss - BWL

ACTIVE COMPARATOR

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

Interventions

Behavioral Weight Loss - BWL BEHAVIORAL

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 Weight Loss - BWL; Novel Executive Function Training - NEXT

Novel Executive Function Training - NEXT BEHAVIORAL

Modifies programs like CogSMART and cognitive remediation training to help participants improve executive functioning to adhere to recommendations from BWL.

Novel Executive Function Training - NEXT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Ability to read English at a 6th grade level
• BMI \>25 and ≤45
• Difficulties with executive functioning

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Dr. Dawn Eichen
• Organization: University of California San Diego

deichen@ucsd.edu

858-249-1123

Study Officials

• Dawn Eichen, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Adjunct Professor

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 30, 2018
• Study Start: June 5, 2019
• Primary Completion: January 14, 2023
• Study Completion: January 14, 2023
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2024-02

Locations

US (1)