Trial Outcomes & Findings for Using Mobile Technology to Better Understand and Measure Self-Regulation (NCT NCT03352713)

Last Updated: 2020-01-10

Results Overview

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 of that facet of self-regulation (perseverance, sensation seeking, self-judgment, or mindfulness).

Recruitment status

COMPLETED

Study phase

Target enrollment

185 participants

Primary outcome timeframe

14 days

Results posted on

2020-01-10

Participant Flow

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	185
Overall Study COMPLETED	159
Overall Study NOT COMPLETED	26

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 Lost to Follow-up	8
Overall Study Withdrawn by investigator	5
Overall Study Completed 0 EMAs	8
Overall Study Device incompatible/stolen	5

Baseline Characteristics

Three participants were lost to follow-up and did not provide these data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laddr n=185 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, Continuous	35.2 years STANDARD_DEVIATION 7.9 • n=185 Participants
Sex/Gender, Customized Male	37 Participants n=185 Participants
Sex/Gender, Customized Female	145 Participants n=185 Participants
Sex/Gender, Customized Non-binary/third gender	3 Participants n=185 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=185 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=185 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=185 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=185 Participants
Race (NIH/OMB) Asian	0 Participants n=185 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=185 Participants
Race (NIH/OMB) Black or African American	12 Participants n=185 Participants
Race (NIH/OMB) White	165 Participants n=185 Participants
Race (NIH/OMB) More than one race	7 Participants n=185 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=185 Participants
Region of Enrollment United States	185 participants n=185 Participants
Short Form Self-Regulation Questionnaire (SSRQ)	102.5 units on a scale STANDARD_DEVIATION 17.1 • n=182 Participants • Three participants were lost to follow-up and did not provide these data.

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	Laddr n=159 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.
12-item Momentary Self-regulation Questionnaire Momentary Perseverance	3.0 scores on a scale Standard Deviation 1.2
12-item Momentary Self-regulation Questionnaire Momentary Sensation Seeking	2.2 scores on a scale Standard Deviation 0.8
12-item Momentary Self-regulation Questionnaire Momentary Self-Judgment	1.9 scores on a scale Standard Deviation 1.1
12-item Momentary Self-regulation Questionnaire Momentary Mindfulness	3.9 scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 14 days

Population: Binge eating sample

\[Binge eating sample only\] 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 control.

Outcome measures

Outcome measures
Measure	Laddr n=77 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.
Binge Eating Episodes [Binge Eating Sample Only]	350 binge eating episodes

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Laddr n=82 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.
Smoking Episodes [Smoking Sample Only]	2891 smoking episodes

Adverse Events

Laddr

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shea Lemley

Center for Technology and Behavioral Health, Dartmouth Geisel School of Medicine

Phone: 603-646-7040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place