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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK114480 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Executive Function Training - NEXT | Experimental | Same as BWL with some additional strategies targeted at improving executive function to help adherence to BWL skills. |
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| Behavioral Weight Loss - BWL | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Weight Loss - BWL | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Measured by Attendance | Number of Treatment Sessions Attended | Over the course of 6 months of treatment |
| Acceptability | Ratings of usefulness of treatment | At 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| BMI Change | change in BMI (kg/m2) | From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months) |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Eichen, PhD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Center for Healthy Eating and Activity Research (CHEAR | La Jolla | California | 92093 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Measured by Attendance | Number of Treatment Sessions Attended | total intention to treat sample evaluated | Posted | Median | Inter-Quartile Range | Sessions | Over the course of 6 months of treatment |
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From baseline assessment through 6 months follow-up (~12 months)
At each assessment timepoint following baseline (mid-treatment, post-treatment, and 6-month follow-up) participants were asked about any changes to medications and any changes to their health conditions/diagnoses
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn Eichen | University of California San Diego | 858-249-1123 | deichen@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2021 | Jan 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Novel Executive Function Training - NEXT | Behavioral | Modifies programs like CogSMART and cognitive remediation training to help participants improve executive functioning to adhere to recommendations from BWL. |
|
| From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | Acceptability | Ratings of usefulness of treatment | Includes all participants who responded to the acceptability survey at post-treatment. | Posted | Count of Participants | Participants | At 6 months |
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| Other Pre-specified | BMI Change | change in BMI (kg/m2) | All available data were used but at some timepoints data was missing. Numbers analyzed represent number of individuals providing data at each timepoint. | Posted | Mean | Standard Deviation | kg/m2 | From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months) |
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| 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. | Numbers per row represent numbers of individual providing data for this specific measure at each timepoint. All analyses conducted are intent to treat framework. | Posted | Mean | Standard Deviation | T-score | From baseline through mid-treatment (3 months), post-treatment (6 months), and 6-month follow-up (12 months) |
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| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 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. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Mid-Treatment BMI |
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| Post-Treatment BMI |
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| 6-Month Follow-up BMI |
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| Mid-Treatment GEC |
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| Post-Treatment GEC |
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| 6-Month Follow-up GEC |
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