N/A
N=91
Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Smoking · Binge Eating · Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03687658 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Binge Eating Episodes - Loss of Control — 0.212 episodes — p=0.066
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laddr (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge Eating Episodes - Loss of Control |
0.212 | 0.066 |
| PRIMARY Binge Eating Episodes - Overeating |
0.286 | 0.273 |
| PRIMARY Number of Cigarettes Smoked Per Day |
2.97 | 0.403 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03687658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.