Trial Outcomes & Findings for Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating (NCT NCT03687658)

Last Updated: 2023-09-28

Results Overview

Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period.

Recruitment status

COMPLETED

Study phase

Target enrollment

91 participants

Primary outcome timeframe

28 days

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Binge Eating Group Overweight participants with binge eating disorder were administered Laddr over 4 weeks.	Smoking Group Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks.
Overall Study STARTED	67	24
Overall Study Completed 1st Scan	52	20
Overall Study Completed 2nd Scan	46	10
Overall Study COMPLETED	46	10
Overall Study NOT COMPLETED	21	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Binge Eating Group n=46 Participants Overweight participants with binge eating disorder were administered Laddr over 4 weeks.	Smoking Group n=10 Participants Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks.	Total n=56 Participants Total of all reporting groups
Age, Continuous	32.80 years STANDARD_DEVIATION 8.27 • n=5 Participants	39.7 years STANDARD_DEVIATION 8.6 • n=7 Participants	34.04 years STANDARD_DEVIATION 8.67 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	2 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	1 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	9 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	2 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	7 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	46 Participants n=5 Participants	10 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.

Outcome measures

Outcome measures
Measure	Binge Eating Group n=46 Participants Overweight participants with binge eating disorder were administered Laddr over 4 weeks.
Binge Eating Episodes - Loss of Control	0.212 episodes Standard Error 0.0213

PRIMARY outcome

Timeframe: 28 days

Population: Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.

Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). 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). Responses provided were averaged across the 28-day period.

Outcome measures

Outcome measures
Measure	Binge Eating Group n=46 Participants Overweight participants with binge eating disorder were administered Laddr over 4 weeks.
Binge Eating Episodes - Overeating	0.286 episodes Standard Error 0.0235

PRIMARY outcome

Timeframe: 28 days

Population: Participants in the Smoking Group only and completed both scans were evaluated for this outcome.

Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). 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 and this was averaged over the 28 day period.

Outcome measures

Outcome measures
Measure	Binge Eating Group n=10 Participants Overweight participants with binge eating disorder were administered Laddr over 4 weeks.
Number of Cigarettes Smoked Per Day	2.97 cigarettes per day Standard Error 0.547

Adverse Events

Binge Eating Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smoking Group

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

Russell Poldrack, PhD

Stanford University

Phone: (650) 497-8488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place