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NCT03352713

Using Mobile Technology to Better Understand and Measure Self-Regulation

Completed NA Results posted Last updated 10 January 2020
What this trial tests

NA trial testing Laddr in Self-regulation in 185 participants. Completed in 3 December 2018.

Timeline
11 January 2018
Primary endpoint
29 November 2018
3 December 2018

Quick facts

Lead sponsorDartmouth-Hitchcock Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment185
Start date11 January 2018
Primary completion29 November 2018
Estimated completion3 December 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

Adults 21 to 50, any sex, with Self-regulation or Binge Eating. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

12-item Momentary Self-regulation Questionnaire Primary · 14 days

Self-reported momentary self-regulation assessed by the momentary self-regulation questionnaire four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. Each item is scored 1 (not at all) to 5 (extremely). The scale is comprised of four subscales: momentary perseverance, momentary sensation seeking, momentary self-judgment, and momentary mindfulness. Each subscale score is calculated by averaging the responses from three of the scale items. Scores on each subscale range from 1 to 5, with higher subscale scores indicating greater momentary reporting o

Momentary Perseverance
GroupValue95% CI
Laddr3.0± 1.2
Momentary Sensation Seeking
GroupValue95% CI
Laddr2.2± 0.8
Momentary Self-Judgment
GroupValue95% CI
Laddr1.9± 1.1
Momentary Mindfulness
GroupValue95% CI
Laddr3.9± 1.1
Binge Eating Episodes [Binge Eating Sample Only] Secondary · 14 days

\[Binge eating sample only\] Self-reported binge eating episodes assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. 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). Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 1 (not at all) to 5 (totally), where a 4 or 5 is considered loss of

GroupValue95% CI
Laddr350
Smoking Episodes [Smoking Sample Only] Secondary · 14 days

\[Smoking sample only\] Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. 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.

GroupValue95% CI
Laddr2891

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Momentary Influences on Self-Regulation in Two Populations With Health Risk Behaviors: Adults Who Smoke and Adults Who Are Overweight and Have Binge-Eating Disorder.
    Scherer EA, Metcalf SA, Whicker CL, Bartels SM, et al · · 2022 · cited 8× · PMID 35373179 · DOI 10.3389/fdgth.2022.798895

Verify or expand the search:

Other trials of Laddr

Trials testing the same drug.

Other recruiting trials for Self-regulation

Currently open trials in the same condition.

Other Dartmouth-Hitchcock Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03352713.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing