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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3DA041713-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain within and outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. This is the fourth phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binge Eating Group | Experimental | All participants in the study will be invited to use Laddr, described in the intervention section. |
|
| Smoking Group | Experimental | All participants in the study will be invited to use Laddr, described in the intervention section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laddr | Behavioral | Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not "diagnosis-specific" but rather enables integrated care for any combination of individuals' goals, needs, and preferences. |
| Measure | Description | Time Frame |
|---|---|---|
| Binge Eating Episodes - Loss of Control | Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period. | 28 days |
| Binge Eating Episodes - Overeating | Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question "Since the last prompt, when you ate most recently, did you overeat?" and is scored as 0 (no) or 1 (yes). Responses provided were averaged across the 28-day period. | 28 days |
| Number of Cigarettes Smoked Per Day | Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question "Since the last prompt, how many cigarettes have you smoked?" Participants are asked to input a number into a number field and this was averaged over the 28 day period. | 28 days |
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Inclusion Criteria:
Additional Inclusion Criteria for Smoking sample:
Additional Inclusion Criteria for Binge Eating Sample:
Exclusion Criteria:
Additional Exclusion criteria for Binge Eating Sample:
Additional Exclusion Criteria for Smoking Sample:
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| Name | Affiliation | Role |
|---|---|---|
| Russell A Poldrack, PhD | Stanford University | Principal Investigator |
| Patrick G Bissett, PhD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Center for Cognitive and Neurobiological Imaging | Stanford | California | 94305 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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After completion of the study, a de-identified dataset (i.e., stripped of all codes or other information that could be linked back to an individual participant) will be generated and made available to the research community as a whole.
Data will be available upon submission of the paper detailing the findings of the research.
All data will be shared openly, with no restrictions on access.
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| ID | Title | Description |
|---|---|---|
| FG000 | Binge Eating Group | Overweight participants with binge eating disorder were administered Laddr over 4 weeks. |
| FG001 | Smoking Group | Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed both scans are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Binge Eating Group | Overweight participants with binge eating disorder were administered Laddr over 4 weeks. |
| BG001 | Smoking Group | Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Binge Eating Episodes - Loss of Control | Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period. | Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome. | Posted | Mean | Standard Error | episodes | 28 days |
|
Average approximately 5 weeks
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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 | Binge Eating Group | Overweight participants with binge eating disorder were administered Laddr over 4 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Poldrack, PhD | Stanford University | (650) 497-8488 | poldrack@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2021 | Aug 29, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2023 | Aug 30, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2021 | Aug 5, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D002032 | Bulimia |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Binge Eating Episodes - Overeating | Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question "Since the last prompt, when you ate most recently, did you overeat?" and is scored as 0 (no) or 1 (yes). Responses provided were averaged across the 28-day period. | Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome. | Posted | Mean | Standard Error | episodes | 28 days |
|
|
|
|
| Primary | Number of Cigarettes Smoked Per Day | Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question "Since the last prompt, how many cigarettes have you smoked?" Participants are asked to input a number into a number field and this was averaged over the 28 day period. | Participants in the Smoking Group only and completed both scans were evaluated for this outcome. | Posted | Mean | Standard Error | cigarettes per day | 28 days |
|
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Smoking Group | Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks. | 0 | 24 | 0 | 24 | 0 | 24 |
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