Trial Outcomes & Findings for Novel Executive Function Training for Obesity (NCT NCT03724396)
NCT ID: NCT03724396
Last Updated: 2024-02-15
Results Overview
Number of Treatment Sessions Attended
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Over the course of 6 months of treatment
Results posted on
2024-02-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
Mid Treatment
|
33
|
32
|
|
Overall Study
Post-Treatment
|
32
|
31
|
|
Overall Study
6-month Follow-up
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Novel Executive Function Training for Obesity
Baseline characteristics by cohort
| Measure |
Novel Executive Function Training - NEXT
n=34 Participants
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.
|
Behavioral Weight Loss - BWL
n=33 Participants
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.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over the course of 6 months of treatmentPopulation: total intention to treat sample evaluated
Number of Treatment Sessions Attended
Outcome measures
| Measure |
Novel Executive Function Training - NEXT
n=34 Participants
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.
|
Behavioral Weight Loss - BWL
n=33 Participants
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.
|
|---|---|---|
|
Feasibility as Measured by Attendance
|
18 Sessions
Interval 17.0 to 19.0
|
18 Sessions
Interval 16.0 to 19.0
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Includes all participants who responded to the acceptability survey at post-treatment.
Ratings of usefulness of treatment
Outcome measures
| Measure |
Novel Executive Function Training - NEXT
n=31 Participants
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.
|
Behavioral Weight Loss - BWL
n=30 Participants
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.
|
|---|---|---|
|
Acceptability
Strongly Agreed or Agreed that treatment helped develop healthy habits
|
25 Participants
|
26 Participants
|
|
Acceptability
Strongly Agreed or Agreed that they would recommend the program to a friend
|
28 Participants
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
change in BMI (kg/m2)
Outcome measures
| Measure |
Novel Executive Function Training - NEXT
n=34 Participants
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.
|
Behavioral Weight Loss - BWL
n=33 Participants
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.
|
|---|---|---|
|
BMI Change
Baseline BMI
|
33.3 kg/m2
Standard Deviation 4.3
|
33.2 kg/m2
Standard Deviation 5.5
|
|
BMI Change
Mid-Treatment BMI
|
32.6 kg/m2
Standard Deviation 4.4
|
32.5 kg/m2
Standard Deviation 5.6
|
|
BMI Change
Post-Treatment BMI
|
32.0 kg/m2
Standard Deviation 4.8
|
31.7 kg/m2
Standard Deviation 5.8
|
|
BMI Change
6-Month Follow-up BMI
|
32.4 kg/m2
Standard Deviation 4.7
|
33.1 kg/m2
Standard Deviation 6.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Novel Executive Function Training - NEXT
n=34 Participants
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.
|
Behavioral Weight Loss - BWL
n=33 Participants
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.
|
|---|---|---|
|
Executive Function
Baseline GEC
|
57.4 T-score
Standard Deviation 12.7
|
57.2 T-score
Standard Deviation 12.5
|
|
Executive Function
Mid-Treatment GEC
|
58.1 T-score
Standard Deviation 12.9
|
55.3 T-score
Standard Deviation 11.2
|
|
Executive Function
Post-Treatment GEC
|
56.1 T-score
Standard Deviation 13.7
|
59.5 T-score
Standard Deviation 11.7
|
|
Executive Function
6-Month Follow-up GEC
|
57.1 T-score
Standard Deviation 13.0
|
59.2 T-score
Standard Deviation 11.0
|
Adverse Events
Novel Executive Function Training - NEXT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Weight Loss - BWL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place