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Novel Executive Function Training for Obesity

Not Applicable
Completed
Conditions
Overweight and Obesity
Interventions
Behavioral: Behavioral Weight Loss - BWL
Behavioral: Novel Executive Function Training - NEXT
Registration Number
NCT03724396
Lead Sponsor
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.

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. Treatment will be 6 months long and assessments will occur at baseline, mid-treatment, post-treatment and 6-months after treatment.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
67
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Novel Executive Function Training - NEXTBehavioral Weight Loss - BWLSame as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.
Behavioral Weight Loss - BWLBehavioral Weight Loss - BWLAll 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 - NEXTNovel Executive Function Training - NEXTSame as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.
Primary Outcome Measures
NameTimeMethod
Feasibility as Measured by AttendanceOver the course of 6 months of treatment

Number of Treatment Sessions Attended

AcceptabilityAt 6 months

Ratings of usefulness of treatment

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR

🇺🇸

La Jolla, California, United States

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