Novel Executive Function Training for Obesity (NEXT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03724396 |
Recruitment Status :
Active, not recruiting
First Posted : October 30, 2018
Last Update Posted : December 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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Overweight and Obesity | Behavioral: Behavioral Weight Loss - BWL Behavioral: Novel Executive Function Training - NEXT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 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 |

Arm | Intervention/treatment |
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Experimental: Novel Executive Function Training - NEXT
Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.
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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.
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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. |
- Feasibility as measured by number of treatment sessions attendned [ Time Frame: Over the course of 6 months of treatment ]Attendance at Treatment Sessions
- Acceptability [ Time Frame: At 6 months ]Ratings of usefulness of treatment
- BMI Change [ Time Frame: Through study completion, an average of 12 months ]change in BMI (kg/m2)
- Executive Function [ Time Frame: Through study completion, an average of 12 months ]Change in executive function measured by BRIEF

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

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
United States, California | |
UCSD Center for Healthy Eating and Activity Research (CHEAR | |
La Jolla, California, United States, 92093 |
Principal Investigator: | Dawn Eichen, PhD | UC San Diego |
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 Key Record Dates |
Last Update Posted: | December 8, 2021 |
Last Verified: | December 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
weight loss executive function |
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |