Using Mobile Technology to Improve Self-Regulation
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|ClinicalTrials.gov Identifier: NCT03774433|
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : October 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Self-regulation Binge Eating Smoking||Behavioral: Laddr||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation - Aim 4 Dartmouth Study: Using Mobile Technology to Improve Self-Regulation|
|Actual Study Start Date :||February 27, 2019|
|Actual Primary Completion Date :||June 29, 2020|
|Actual Study Completion Date :||June 29, 2020|
All participants in the study will be invited to use Laddr, described in the intervention section.
Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not "diagnosis-specific" but rather enables integrated care for any combination of individuals' goals, needs, and preferences.
- Rate of binge eating episodes [binge eating sample only] [ Time Frame: 28 days ][Binge eating sample only] Self-reported binge eating episodes are assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-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 control.
- Rate of smoking episodes [smoking sample only] [ Time Frame: 28 days ][Smoking sample only] Self-reported smoking is assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774433
|United States, New Hampshire|
|Center for Technology and Behavioral Health, Dartmouth College|
|Lebanon, New Hampshire, United States, 03766|
|Principal Investigator:||Lisa A Marsch, PhD||Dartmouth College|