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Novel Executive Function Training for Obesity (NEXT)

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ClinicalTrials.gov Identifier: NCT03724396
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Dawn Eichen, University of California, San Diego

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.

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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

Resource links provided by the National Library of Medicine


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.




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


Secondary 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 NIH Examiner



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-60
  • 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, or IQ<80

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724396


Contacts
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Contact: Dawn Eichen, PhD 858-534-8322 deichen@ucsd.edu
Contact: Kaylen Moline, MPH 1-855-UCSD-4W8 chear@ucsd.edu

Locations
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United States, California
UCSD Center for Healthy Eating and Activity Research (CHEAR Recruiting
La Jolla, California, United States, 92093
Contact: Dawn Eichen, PhD    858-534-8322    deichen@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
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Principal Investigator: Dawn Eichen, PhD UC San Diego

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Responsible Party: Dawn Eichen, Assistant Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03724396     History of Changes
Other Study ID Numbers: K23DK114480 ( U.S. NIH Grant/Contract )
K23DK114480 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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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:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms