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OpenTrials
Completed

NCT Number: NCT03724396

Novel Executive Function Training for Obesity

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.

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Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Center for Healthy Eating and Activity Research (CHEAR

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility as Measured by Attendance

    Time frame: Over the course of 6 months of treatment

    Number of Treatment Sessions Attended

  2. Acceptability

    Time frame: At 6 months

    Ratings of usefulness of treatment

Other outcomes

  1. BMI Change

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

    change in BMI (kg/m2)

  2. Executive Function

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

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Acronym: NEXT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2018
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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