Back to resultsApplying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Primary Purpose
Smoking, Binge Eating, Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laddr
Sponsored by
About this trial
This is an interventional basic science trial for Smoking
Eligibility Criteria
Inclusion Criteria:
- Understand English sufficiently to provide informed consent
- Right-handed
- Normal or corrected-to-normal vision and no color blindness
- Interest in engaging with Laddr to modify self-regulatory behavior
Additional Inclusion Criteria for Smoking sample:
- Smoke 5 or more tobacco cigarettes/day for past year
- BMI greater than or equal to 17 and less than 27
Additional Inclusion Criteria for Binge Eating Sample:
- BMI greater than or equal to 27 and less than 45
- Weight limit of 350 lbs
- Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)
Exclusion Criteria:
- Significant medical illness
- History of mental disorder due to a medical condition
- Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
- Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)
Additional Exclusion criteria for Binge Eating Sample:
- Lost weight in recent past (>10 pounds in past 6 months)
- Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)
- Currently on a special diet for a serious health condition
- Current engagement in psychotherapy for binge eating disorder
Additional Exclusion Criteria for Smoking Sample:
- Binge eating behavior
- Current engagement in psychotherapy for smoking behavior
Sites / Locations
- Stanford Center for Cognitive and Neurobiological Imaging
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Binge Eating Group
Smoking Group
Arm Description
All participants in the study will be invited to use Laddr, described in the intervention section.
All participants in the study will be invited to use Laddr, described in the intervention section.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03687658
First Posted
September 26, 2018
Last Updated
August 31, 2023
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03687658
Brief Title
Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Official Title
Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Binge Eating, Behavior
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Binge Eating Group
Arm Type
Experimental
Arm Description
All participants in the study will be invited to use Laddr, described in the intervention section.
Arm Title
Smoking Group
Arm Type
Experimental
Arm Description
All participants in the study will be invited to use Laddr, described in the intervention section.
Intervention Type
Behavioral
Intervention Name(s)
Laddr
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binge Eating Episodes - Loss of Control
Description
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.
Time Frame
28 days
Title
Binge Eating Episodes - Overeating
Description
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.
Time Frame
28 days
Title
Number of Cigarettes Smoked Per Day
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Understand English sufficiently to provide informed consent
Right-handed
Normal or corrected-to-normal vision and no color blindness
Interest in engaging with Laddr to modify self-regulatory behavior
Additional Inclusion Criteria for Smoking sample:
Smoke 5 or more tobacco cigarettes/day for past year
BMI greater than or equal to 17 and less than 27
Additional Inclusion Criteria for Binge Eating Sample:
BMI greater than or equal to 27 and less than 45
Weight limit of 350 lbs
Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)
Exclusion Criteria:
Significant medical illness
History of mental disorder due to a medical condition
Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)
Additional Exclusion criteria for Binge Eating Sample:
Lost weight in recent past (>10 pounds in past 6 months)
Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)
Currently on a special diet for a serious health condition
Current engagement in psychotherapy for binge eating disorder
Additional Exclusion Criteria for Smoking Sample:
Binge eating behavior
Current engagement in psychotherapy for smoking behavior
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell A Poldrack, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick G Bissett, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Center for Cognitive and Neurobiological Imaging
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available upon submission of the paper detailing the findings of the research.
IPD Sharing Access Criteria
All data will be shared openly, with no restrictions on access.
Links:
URL
https://scienceofbehaviorchange.org/what-is-sobc/
Description
Related Info
Learn more about this trial
Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
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