Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Binge Eating Group All participants in the study will be invited to use Laddr, described in the intervention section. |
Behavioral: Laddr
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.
|
| Experimental: Smoking Group All participants in the study will be invited to use Laddr, described in the intervention section. |
Behavioral: Laddr
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.
|
Outcome Measures
Primary Outcome Measures
- Binge eating episodes [binge eating sample only] [28 days]
[Binge eating sample only] Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-day period. 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). Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 1 (not at all) to 5 (totally), where a 4 or 5 is considered loss of control.
- Smoking episodes [smoking sample only] [Time Frame: 28 days]]
[Smoking sample only] Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-day period. 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Center for Cognitive and Neurobiological Imaging | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- National Institutes of Health (NIH)
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Russell A Poldrack, PhD, Stanford University
- Study Director: Patrick G Bissett, PhD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 47143
- 4UH3DA041713-04