Status:
COMPLETED
Using Mobile Technology to Better Understand and Measure Self-Regulation
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Self-regulation
Binge Eating
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain outside of laboratory settings in samples of smokers and overweight/obese i...
Detailed Description
Health risk behavior, including poor diet, physical inactivity, tobacco and other substance use, causes as much as 40% of the illness, suffering, and early death related to chronic diseases. Non-adher...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 21-50 years
- Understand English sufficiently to provide informed consent
- Use a smartphone (participants without mobile sensing); proficient with using smartphone and comfort wearing devices (participants with mobile sensing)
- Additional inclusion criteria for binge eating sample:
- 27 ≤ BMI ≤ 45 kg/m2
- Have binge eating disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)
- Additional inclusion criteria for smoking sample:
- Smoke 5 or more tobacco cigarettes/day for past year
- 17 ≤ BMI \< 27 kg/m2
- Exclusion criteria:
- Any current substance use disorder
- o Will not exclude based on use of substances
- Currently pregnant or plans to become pregnant in next 3 months
- Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
- Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)
- Current use of prescription pain medications (e.g., Vicodin, oxycodone)
- Current use of any medication for smoking
- Exceptions: short-acting nicotine replacement therapy (e.g., gum, lozenge, nasal spray, inhaler)
- Will screen out for Wellbutrin or varenicline
- Current use of any medication for weight loss
- Have undergone weight-loss surgery (e.g., gastric bypass, lap band)
- Current nighttime shift work or obstructive sleep apnea
- Note: We will not exclude based on e-cigarette use.
- Additional exclusion criteria for binge eating sample:
- Compensatory behavior (e.g., purging, excessive exercise, fasting) \[already excluded as part of the DSM-5 binge eating disorder criteria\]
- Lost weight in recent past (\>10 pounds in past 6 months)
- Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig) \[will not exclude on online/mobile app weight-loss programs\]
- Currently on a special diet for a serious health condition
- Additional exclusion criteria for smoking sample:
- Binge eating behavior according to Questionnaire on Eating and Weight Patterns-5 (QEWP-5) ("yes" to Qs 8 and 9 and for Q10, at least one episode per week for three months).
- \- QEWP-5 #8: During the past three months, did you ever eat in a short period of time (for example, a two-hour period) what most people would think was an unusually large amount of food? \[yes or no\]
- \- QEWP-5 #9: During the times when you ate an unusually large amount of food, did you ever feel you could not stop eating or control what or how much you were eating? \[yes or no\]
- \- QEWP-5 #10: During the past three months, how often, on average, did you have episodes like this? That is, eating large amounts of food plus the feeling that your eating was out of control? (There may have been some weeks when this did not happen. Just average those in.) \[less than one episode per week, five response options for 1 or more episodes per week\]
Exclusion
Key Trial Info
Start Date :
January 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2018
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT03352713
Start Date
January 11 2018
End Date
December 3 2018
Last Update
January 10 2020
Active Locations (1)
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1
Center for Technology and Behavioral Health, Dartmouth College
Lebanon, New Hampshire, United States, 03766