Trial Outcomes & Findings for Using Mobile Technology to Improve Self-Regulation (NCT NCT03774433)

Last Updated: 2021-08-24

Results Overview

\[Binge eating sample only\] 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. We are reporting the mean and standard deviations of the target behavior for each sample by week (i.e., Week 1, Week 2, Week 3, and Week 4). Data were averaged for all assessments each week to calculate the number of binge-eating episodes per week.

Recruitment status

COMPLETED

Study phase

Target enrollment

114 participants

Primary outcome timeframe

28 days

Results posted on

2021-08-24

Participant Flow

Participants were recruited from online (e.g., Craigslist, Facebook, Google AdWords) between 2/27/19 and 6/29/20.

Participant milestones

Participant milestones
Measure	Laddr All participants in the study will be invited to use Laddr, described in the intervention section. Laddr: 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.
Overall Study STARTED	114
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Laddr All participants in the study will be invited to use Laddr, described in the intervention section. Laddr: 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.
Overall Study Participants who completed less than 12 EMAs are not included in the final analysis	14

Baseline Characteristics

Using Mobile Technology to Improve Self-Regulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laddr n=114 Participants All participants in the study will be invited to use Laddr, described in the intervention section. Laddr: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	114 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.83 years n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	114 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Participants included completed \>10% (at least 12) EMAs.

Outcome measures

Outcome measures
Measure	Laddr n=50 Participants All participants in the study will be invited to use Laddr, described in the intervention section. Laddr: 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] week 1 (self-reported overeating behavior)	0.256 binge eating episodes Standard Deviation 0.437
Rate of Binge Eating Episodes [Binge Eating Sample Only] week 2 (self-reported overeating behavior)	0.210 binge eating episodes Standard Deviation 0.408
Rate of Binge Eating Episodes [Binge Eating Sample Only] week 3 (self-reported overeating behavior)	0.219 binge eating episodes Standard Deviation 0.414
Rate of Binge Eating Episodes [Binge Eating Sample Only] week 4 (self-reported overeating behavior)	0.205 binge eating episodes Standard Deviation 0.404
Rate of Binge Eating Episodes [Binge Eating Sample Only] week 1 (self-reported lost control behavior)	0.170 binge eating episodes Standard Deviation 0.376
Rate of Binge Eating Episodes [Binge Eating Sample Only] week 2 (self-reported lost control behavior)	0.167 binge eating episodes Standard Deviation 0.373
Rate of Binge Eating Episodes [Binge Eating Sample Only] week 3 (self-reported lost control behavior)	0.135 binge eating episodes Standard Deviation 0.312
Rate of Binge Eating Episodes [Binge Eating Sample Only] week 4 (self-reported lost control behavior)	0.148 binge eating episodes Standard Deviation 0.355

PRIMARY outcome

Timeframe: 28 days

Population: Participants included completed \>10% (at least 12) EMAs.

\[Smoking sample only\] 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. We are reporting the mean and standard deviations of the target behavior for each sample by week (i.e., Week 1, Week 2, Week 3, and Week 4). Data were averaged for all assessments each week to calculate the number of cigarettes smoked per week.

Outcome measures

Outcome measures
Measure	Laddr n=50 Participants All participants in the study will be invited to use Laddr, described in the intervention section. Laddr: 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 Smoking Episodes [Smoking Sample Only] Week 1 (self-reported smoking of more than zero cigarettes)	0.841 cigarettes Standard Deviation 0.366
Rate of Smoking Episodes [Smoking Sample Only] Week 2 (self-reported smoking of more than zero cigarettes)	0.706 cigarettes Standard Deviation 0.456
Rate of Smoking Episodes [Smoking Sample Only] Week 3 (self-reported smoking of more than zero cigarettes)	0.640 cigarettes Standard Deviation 0.480
Rate of Smoking Episodes [Smoking Sample Only] Week 4 (self-reported smoking of more than zero cigarettes)	0.606 cigarettes Standard Deviation 0.489

Adverse Events

Laddr

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Laddr n=114 participants at risk All participants in the study will be invited to use Laddr, described in the intervention section. Laddr: 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.
Injury, poisoning and procedural complications Facial Fractures	0.88% 1/114 • Adverse event data were collected between the Baseline and the Follow-Up Assessment. After a participant completed the Baseline Assessment, they would start their 28-day study period. At the end of their 28-day study period, they completed one Follow-Up Assessment.

Other adverse events

Other adverse events
Measure	Laddr n=114 participants at risk All participants in the study will be invited to use Laddr, described in the intervention section. Laddr: 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.
Blood and lymphatic system disorders Deep Vein Thrombosis	0.88% 1/114 • Adverse event data were collected between the Baseline and the Follow-Up Assessment. After a participant completed the Baseline Assessment, they would start their 28-day study period. At the end of their 28-day study period, they completed one Follow-Up Assessment.

Additional Information

Dr. Lisa Marsch

Dartmouth College

Phone: 603-646-7092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place