N/A
N=185
Using Mobile Technology to Better Understand and Measure Self-Regulation
Self-regulation · Binge Eating · Smoking
Bottom Line
View on ClinicalTrials.gov: NCT03352713 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: 12-item Momentary Self-regulation Questionnaire — 3.0; 2.2; 1.9; 3.9 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laddr (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12-item Momentary Self-regulation Questionnaire |
3.0; 2.2; 1.9; 3.9 | — |
| SECONDARY Binge Eating Episodes [Binge Eating Sample Only] |
350 | — |
| SECONDARY Smoking Episodes [Smoking Sample Only] |
2891 | — |
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 individuals with binge eating disorder. Fifty smokers and 50 overweight/obese individuals with binge eating disorder will be recruited to participate in a non-lab experimental paradigm in which we will leverage our novel mobile behavioral assessment/intervention technology platform. We will measure and modulate engagement of potential self-regulation targets and collect data in real time and in real-world conditions. Mobile sensing will be added to up to 50 additional participants.
Eligibility Criteria
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 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]
Data sourced from ClinicalTrials.gov (NCT03352713). 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.