NCT03724396: NEXT

Novel Executive Function Training for Obesity

Completed NA Results posted Last updated 15 February 2024

What this trial tests

NA trial testing Behavioral Weight Loss - BWL in Overweight and Obesity in 67 participants. Completed in 14 January 2023.

Timeline

5 June 2019

Primary endpoint
14 January 2023

14 January 2023

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	67
Start date	5 June 2019
Primary completion	14 January 2023
Estimated completion	14 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Behavioral Weight Loss - BWL
• Novel Executive Function Training - NEXT

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 65, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility as Measured by Attendance Primary · Over the course of 6 months of treatment

Number of Treatment Sessions Attended

Group	Value	95% CI
Novel Executive Function Training - NEXT	18	17 – 19
Behavioral Weight Loss - BWL	18	16 – 19

Acceptability Primary · At 6 months

Ratings of usefulness of treatment

Strongly Agreed or Agreed that treatment helped develop healthy habits

Group	Value	95% CI
Novel Executive Function Training - NEXT	25
Behavioral Weight Loss - BWL	26

Strongly Agreed or Agreed that they would recommend the program to a friend

Group	Value	95% CI
Novel Executive Function Training - NEXT	28
Behavioral Weight Loss - BWL	24

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

change in BMI (kg/m2)

Baseline BMI

Group	Value	95% CI
Novel Executive Function Training - NEXT	33.3	± 4.3
Behavioral Weight Loss - BWL	33.2	± 5.5

Mid-Treatment BMI

Group	Value	95% CI
Novel Executive Function Training - NEXT	32.6	± 4.4
Behavioral Weight Loss - BWL	32.5	± 5.6

Post-Treatment BMI

Group	Value	95% CI
Novel Executive Function Training - NEXT	32.0	± 4.8
Behavioral Weight Loss - BWL	31.7	± 5.8

6-Month Follow-up BMI

Group	Value	95% CI
Novel Executive Function Training - NEXT	32.4	± 4.7
Behavioral Weight Loss - BWL	33.1	± 6.5

Executive Function Secondary · 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.

Baseline GEC

Group	Value	95% CI
Novel Executive Function Training - NEXT	57.4	± 12.7
Behavioral Weight Loss - BWL	57.2	± 12.5

Mid-Treatment GEC

Group	Value	95% CI
Novel Executive Function Training - NEXT	58.1	± 12.9
Behavioral Weight Loss - BWL	55.3	± 11.2

Post-Treatment GEC

Group	Value	95% CI
Novel Executive Function Training - NEXT	56.1	± 13.7
Behavioral Weight Loss - BWL	59.5	± 11.7

6-Month Follow-up GEC

Group	Value	95% CI
Novel Executive Function Training - NEXT	57.1	± 13.0
Behavioral Weight Loss - BWL	59.2	± 11.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.