Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating

Study Overview
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Brief Summary
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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.

Official Title
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Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4

Conditions
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Smoking, Binge Eating, Behavior

Intervention / Treatment
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* Behavioral: Laddr


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binge Eating Group<br>All participants in the study will be invited to use Laddr, described in the intervention section. | Behavioral: Laddr<br>* 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.<br>|
| Experimental: Smoking Group<br>All participants in the study will be invited to use Laddr, described in the intervention section. | Behavioral: Laddr<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |