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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687658
• Other study ID #: 47143
• Secondary ID: 4UH3DA041713-04
• Status: Completed
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Smoking

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Center for Cognitive and Neurobiological Imaging	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	28 days
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.	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.	28 days

External Links

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