N/A
N=114
Using Mobile Technology to Improve Self-Regulation
Self-regulation · Binge Eating · Smoking
Bottom Line
View on ClinicalTrials.gov: NCT03774433 ↗Enrolled (actual)
114
Serious AEs
0.9%
Results posted
Aug 2021
Primary outcome: Primary: Rate of Binge Eating Episodes [Binge Eating Sample Only] — 0.256; 0.210; 0.219; 0.205 binge eating episodes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laddr (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Binge Eating Episodes [Binge Eating Sample Only] |
0.256; 0.210; 0.219; 0.205; 0.170; 0.167 | — |
| PRIMARY Rate of Smoking Episodes [Smoking Sample Only] |
0.841; 0.706; 0.640; 0.606 | — |
Summary
This study will evaluate the degree to which engaging targets produces a desired change in medical regimen adherence (across 4-week interventions) and health behavior among smokers (n=50) and overweight/obese persons with binge eating disorder (n=50) (smoking in the former sample and binge eating in the latter sample). The investigators will employ a novel mobile behavioral assessment/intervention platform to engage targets in these samples, given that (1) it offers self-regulation assessment and behavior change tools via an integrated platform to a wide array of populations, and (2) content within the platform can be quickly modified as needed to better impact targets. This is the fourth and final phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.
This trial builds on NCT03352713.
Eligibility Criteria
Inclusion criteria
- Age 18-50 years
- Understand English sufficiently to provide informed consent
- Access to a computer in a setting in which the participant is comfortable providing sensitive information
- Use a smartphone operating system compatible with Laddr
Additional inclusion criteria for binge eating sample:
- 27 ≤ BMI ≤ 45 kg/m2
- Have binge eating disorder according to DSM-5 criteria
- Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)
- Confirmed interest in an eating intervention
- Use a smartphone compatible with Fitbit
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)
o Will ask about, but won't exclude on, online/mobile app weight-loss programs as part of the screener
- Currently on a special diet for a serious health condition
- Currently in therapy with a clinician for binge eating
- Nickel allergy (because Fitbit band contains nickel)
Additional exclusion criteria for smoking sample:
- Currently in therapy with a clinician for smoking
- Binge eating behavior
Data sourced from ClinicalTrials.gov (NCT03774433). 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.