Overweight and Obesity
Conditions
Keywords
weight loss, executive function
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALNovel Executive Function Training - NEXT
Modifies programs like CogSMART and cognitive remediation training to help participants improve executive functioning to adhere to recommendations from BWL.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Attendance | Over the course of 6 months of treatment | Number of Treatment Sessions Attended |
| Acceptability | At 6 months | Ratings of usefulness of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| BMI Change | From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months) | change in BMI (kg/m2) |
| Executive Function | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Novel Executive Function Training - NEXT Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills.
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.
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. | 34 |
| 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 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. | 33 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Behavioral Weight Loss - BWL | Total | Novel Executive Function Training - NEXT |
|---|---|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 13.3 | 45.8 years STANDARD_DEVIATION 12.2 | 47.1 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 54 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Female | 27 Participants | 56 Participants | 29 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 |
| other Total, other adverse events | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 |
Outcome results
Primary
Acceptability
Ratings of usefulness of treatment
Time frame: At 6 months
Population: Includes all participants who responded to the acceptability survey at post-treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Novel Executive Function Training - NEXT | Acceptability | Strongly Agreed or Agreed that treatment helped develop healthy habits | 25 Participants |
| Novel Executive Function Training - NEXT | Acceptability | Strongly Agreed or Agreed that they would recommend the program to a friend | 28 Participants |
| Behavioral Weight Loss - BWL | Acceptability | Strongly Agreed or Agreed that treatment helped develop healthy habits | 26 Participants |
| Behavioral Weight Loss - BWL | Acceptability | Strongly Agreed or Agreed that they would recommend the program to a friend | 24 Participants |
Primary
Feasibility as Measured by Attendance
Number of Treatment Sessions Attended
Time frame: Over the course of 6 months of treatment
Population: total intention to treat sample evaluated
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Novel Executive Function Training - NEXT | Feasibility as Measured by Attendance | 18 Sessions |
| Behavioral Weight Loss - BWL | Feasibility as Measured by Attendance | 18 Sessions |
Other Pre-specified
BMI Change
change in BMI (kg/m2)
Time frame: From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)
Population: All available data were used but at some timepoints data was missing. Numbers analyzed represent number of individuals providing data at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Novel Executive Function Training - NEXT | BMI Change | 6-Month Follow-up BMI | 32.4 kg/m2 | Standard Deviation 4.7 |
| Novel Executive Function Training - NEXT | BMI Change | Mid-Treatment BMI | 32.6 kg/m2 | Standard Deviation 4.4 |
| Novel Executive Function Training - NEXT | BMI Change | Baseline BMI | 33.3 kg/m2 | Standard Deviation 4.3 |
| Novel Executive Function Training - NEXT | BMI Change | Post-Treatment BMI | 32.0 kg/m2 | Standard Deviation 4.8 |
| Behavioral Weight Loss - BWL | BMI Change | Baseline BMI | 33.2 kg/m2 | Standard Deviation 5.5 |
| Behavioral Weight Loss - BWL | BMI Change | 6-Month Follow-up BMI | 33.1 kg/m2 | Standard Deviation 6.5 |
| Behavioral Weight Loss - BWL | BMI Change | Post-Treatment BMI | 31.7 kg/m2 | Standard Deviation 5.8 |
| Behavioral Weight Loss - BWL | BMI Change | Mid-Treatment BMI | 32.5 kg/m2 | Standard Deviation 5.6 |
Other Pre-specified
Executive Function
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.
Time frame: From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months)
Population: Numbers per row represent numbers of individual providing data for this specific measure at each timepoint. All analyses conducted are intent to treat framework.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Novel Executive Function Training - NEXT | Executive Function | Baseline GEC | 57.4 T-score | Standard Deviation 12.7 |
| Novel Executive Function Training - NEXT | Executive Function | Mid-Treatment GEC | 58.1 T-score | Standard Deviation 12.9 |
| Novel Executive Function Training - NEXT | Executive Function | Post-Treatment GEC | 56.1 T-score | Standard Deviation 13.7 |
| Novel Executive Function Training - NEXT | Executive Function | 6-Month Follow-up GEC | 57.1 T-score | Standard Deviation 13 |
| Behavioral Weight Loss - BWL | Executive Function | 6-Month Follow-up GEC | 59.2 T-score | Standard Deviation 11 |
| Behavioral Weight Loss - BWL | Executive Function | Baseline GEC | 57.2 T-score | Standard Deviation 12.5 |
| Behavioral Weight Loss - BWL | Executive Function | Post-Treatment GEC | 59.5 T-score | Standard Deviation 11.7 |
| Behavioral Weight Loss - BWL | Executive Function | Mid-Treatment GEC | 55.3 T-score | Standard Deviation 11.2 |