Trial Outcomes & Findings for Weight Loss for Prediabetes Using Episodic Future Thinking (NCT NCT03670602)

Last Updated: 2022-12-09

Results Overview

Delay Discounting will be assessed using an adjusting amount task where choices will be present between a larger, delayed amount of money ($100) and a smaller, immediate amount. The smaller, immediate amount will begin at $50 on the first trial and will be adjusted following each trial. Participants cues created during treatment will be displayed during the task. To calculate discount rates hyperbolic discounting model will be used V=A/1+kD where V is discounted value, A is reward amount, D is delay and k is a free parameter that indexes the rate of discounting. k values are transformed using natural log. Higher scores indicate more choices for immediate reward. Change is assessed using repeated measures.

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

Baseline (0 weeks), 12 weeks and 24 weeks

Results posted on

2022-12-09

Participant Flow

Participants with prediabetes (HbA1c) between 5.7 to 6.4% Participants had no prior or current diagnosis of diabetes, were not pregnant and were not taking medications that influenced their blood glucose.

Participants (n=933) completed a prescreen internet survey and n=294 were screened in our laboratory. N=72 participated in the initial weight loss and 8 participants declined or did not qualify to enroll in the randomized study. 64 participants were randomized between intervention and control groups.

Participant milestones

Participant milestones
Measure	Episodic Future Thinking (EFT) Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Overall Study STARTED	31	33
Overall Study Received Intervention Treatment	30	30
Overall Study Completed Session 2 (Week 12)	29	30
Overall Study Completed Session 3 (Week 24)	28	31
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Episodic Future Thinking (EFT) Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Weight Loss for Prediabetes Using Episodic Future Thinking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.	Total n=64 Participants Total of all reporting groups
Age, Continuous	55.0 Years STANDARD_DEVIATION 10.4 • n=5 Participants	54.1 Years STANDARD_DEVIATION 9.3 • n=7 Participants	54.6 Years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	33 participants n=7 Participants	64 participants n=5 Participants
Body Mass Index (BMI)	37.0 kg/m^2 STANDARD_DEVIATION 7.2 • n=5 Participants	38.0 kg/m^2 STANDARD_DEVIATION 6.9 • n=7 Participants	37.5 kg/m^2 STANDARD_DEVIATION 7.0 • n=5 Participants
HbA1c (%)	5.90 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.29 • n=5 Participants	5.91 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.29 • n=7 Participants	5.90 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.29 • n=5 Participants
Education	15.7 years STANDARD_DEVIATION 2.2 • n=5 Participants	15.5 years STANDARD_DEVIATION 2.3 • n=7 Participants	15.6 years STANDARD_DEVIATION 2.2 • n=5 Participants
Annual Household Income	37500 US$ STANDARD_DEVIATION 27335 • n=5 Participants	48889 US$ STANDARD_DEVIATION 35608 • n=7 Participants	43090 US$ STANDARD_DEVIATION 31892 • n=5 Participants
Delay Discounting	-5.92 ln (k) STANDARD_DEVIATION 2.33 • n=5 Participants	-6.11 ln (k) STANDARD_DEVIATION 3.14 • n=7 Participants	-6.01 ln (k) STANDARD_DEVIATION 2.73 • n=5 Participants
Site Enrollment University at Buffalo	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Site Enrollment Virginia Tech Carillon	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Timing of treatment with COVID-19 by cohort Cohort 1; prior to COVID, in person	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Timing of treatment with COVID-19 by cohort Cohort 2; before and during COVID; 50% in person 50% remote	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Timing of treatment with COVID-19 by cohort Cohort 3 - during COVID, remote	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (0 weeks), 12 weeks and 24 weeks

Population: All participants were analyzed using mixed model methods, 5 participants did not complete DD measures at 12 weeks, and 5 participants did not complete DD measures at 24 weeks

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Change From Baseline in Delay Discounting Baseline Delay Discounting	-5.92 ln (k) Standard Deviation 2.33	-6.11 ln (k) Standard Deviation 3.14
Change From Baseline in Delay Discounting Change from baseline in Delay discounting at 12 weeks	-3.09 ln (k) Standard Deviation 2.63	-0.96 ln (k) Standard Deviation 2.18
Change From Baseline in Delay Discounting Change from baseline in Delay discounting at 24 weeks	-2.79 ln (k) Standard Deviation 2.31	-1.33 ln (k) Standard Deviation 2.04

PRIMARY outcome

Timeframe: Baseline (0 weeks), 12 weeks, and 24 weeks

Population: Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 5 participants did not complete week 12 measures and 4 participants did not complete 24 week height and weight measures

Weight measured in kilograms. Change is assessed using repeated measures.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Change From Baseline in Weight Baseline Weight	102.3 kilograms Standard Deviation 22.3	104.2 kilograms Standard Deviation 23.2
Change From Baseline in Weight Change from baseline in weight at 12 weeks	-6.8 kilograms Standard Deviation 4.3	-7.2 kilograms Standard Deviation 3.8
Change From Baseline in Weight Change from baseline in weight at 24 weeks	-9.8 kilograms Standard Deviation 6.5	-9.8 kilograms Standard Deviation 5.6

PRIMARY outcome

Timeframe: Baseline (0 weeks), 12 weeks and 24 weeks

Population: Analyses were Intention to Treat (ITT) and included all randomized participants. 5 participants did not complete 12 week measures, and 4 participants did not complete 24 week measures.

Glycemic control will be measured as hemoglobin A1c (HbA1c), which is the percentage of glycated hemoglobin within total hemoglobin. Change is assessed using repeated measures.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Change From Baseline in Glycemic Control Baseline hBa1c	5.90 Percentage of glycosylated hemoglobin Standard Deviation 0.29	5.91 Percentage of glycosylated hemoglobin Standard Deviation 0.29
Change From Baseline in Glycemic Control Change from baseline hBa1c at 12 weeks	-0.22 Percentage of glycosylated hemoglobin Standard Deviation 0.36	-0.27 Percentage of glycosylated hemoglobin Standard Deviation 0.28
Change From Baseline in Glycemic Control Change from baseline hBa1c at 24 weeks	-0.35 Percentage of glycosylated hemoglobin Standard Deviation 0.35	-0.39 Percentage of glycosylated hemoglobin Standard Deviation 0.31

SECONDARY outcome

Timeframe: Baseline (0 weeks), 12 weeks and 24 weeks

Population: Analyses were Intention to Treat (ITT) and included all randomized participants, using mixed model analyses. 3 participants did not completed baseline (0) medication adherence measurements, an additional 5 participants did not complete week 12 medication adherence measurements (total missing for change score n =8) and an additional 6 participants did not complete 24 week medication adherence measures (total missing for change score n=9)

Adherence to prescribed medication for co-morbid hypertension and/or hyperlipidemia will be assessed using pill counts. Experimenter will count pills 2x and record number of pills, medication, dosage and fill date. Adherence percentage is calculated \[(Quantity of pills dispensed - remaining)/(quantity prescribed per day\*days since last refill)\] \*100. Change is assessed using repeated measures.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Change in Medication Adherence Change from baseline in medication adherence at 24 weeks	5.23 percent medication adherence Standard Deviation 16.49	0.09 percent medication adherence Standard Deviation 9.5
Change in Medication Adherence Baseline medication adherence	84.3 percent medication adherence Standard Deviation 21.0	91.7 percent medication adherence Standard Deviation 17.2
Change in Medication Adherence Change from baseline in medication adherence at 12 weeks	5.33 percent medication adherence Standard Deviation 17.3	-0.25 percent medication adherence Standard Deviation 19.5

SECONDARY outcome

Timeframe: Baseline (0 weeks), 12 weeks and 24 weeks

Population: Analyses were Intention to Treat (ITT) and included all randomized participants, using mixed model analysis.

Physical activity, as one index of behavioral health and a target of the behavioral weight loss treatment, was measured using an Actigraph Accelerometer. Participants will be asked to wear an Actigraph Accelerometer for at least 10 hours per day for approximately one week. Accelerometer data was filtered using ActiLife, for 90 minutes consecutive non-wear and by participants wear time diaries. The main outcome measure was percent of time engaged in moderate to vigorous activity (MVPA) (MET\>3.00). Change is assessed using repeated measures.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Changes in Physical Activity Baseline percent MVPA	5.61 Percent of time Standard Deviation 2.4	5.67 Percent of time Standard Deviation 2.65
Changes in Physical Activity Change from baseline in percent MVPA at 12 weeks	1.16 Percent of time Standard Deviation 1.95	0.82 Percent of time Standard Deviation 1.77
Changes in Physical Activity Change from baseline in percent MVPA at 24 weeks	0.91 Percent of time Standard Deviation 2.71	0.22 Percent of time Standard Deviation 1.54

SECONDARY outcome

Timeframe: Baseline (0 weeks), 12 weeks and 24 weeks

Population: Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 2 participants did not complete baseline measures, 9 participants did not complete week 12 measures and 10 participants did not complete week 24 measures. One participant did not complete measures at any timepoint.

Dietary intake, as an index of behavioral health and a target of the treatment, was measured using 3 automated self-administered 24-hour multi-pass food recalls. Total calories were averaged across the three sessions for each timepoint. Change was assessed using repeated measures.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Change in Total Calories Baseline total daily calorie intake	1802.2 kilocalories Standard Deviation 591.5	1886.3 kilocalories Standard Deviation 594.7
Change in Total Calories Change from baseline in total daily calorie intake at week 12	-542.5 kilocalories Standard Deviation 599.3	-504.7 kilocalories Standard Deviation 465.0
Change in Total Calories Change from baseline in total daily calorie intake at week 24	-298.4 kilocalories Standard Deviation 458.0	-568.3 kilocalories Standard Deviation 363.5

SECONDARY outcome

Timeframe: Baseline (0 weeks), 12 weeks and 24 weeks

Population: Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 8 participants did not complete week 12 measures and 5 participants did not complete 24 week measures

Visuospatial working memory will be measured using the Backwards Corsi block-tapping task. The total score, or (number of trials completed correctly (out of 14 trials) x longest correctly reported block of items (2 - 8 items) ). Possible scores range from 0 (minimum) - (112) maximum. Higher scores indicate better working memory. Change is assessed using repeated measures

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Changes in Working Memory Change from baseline in Backwards Corsi Total score at 24 weeks	6.9 score Standard Deviation 17.6	4.5 score Standard Deviation 13.5
Changes in Working Memory Baseline Backwards Corsi Total Score	44.6 score Standard Deviation 12.0	46.0 score Standard Deviation 14.0
Changes in Working Memory Change from baseline in backwards Corsi total score at 12 weeks	2.1 score Standard Deviation 18.3	1.6 score Standard Deviation 18.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (0 weeks), 12 weeks and 24 weeks

Population: Analyses were Intent to Treat (ITT) and included all randomized participants, using mixed models. 2 participants did not complete baseline measures, 6 participants did not complete week 12 measures and 6 participants did not complete week 24 measures of relative reinforcing efficacy. Two participants did not complete any measures of relative reinforcing efficacy.

Relative Reinforcing efficacy of food is measured with a hypothetical purchasing task, in which number two foods are available and number of portions of food purchased at various prices ($0 - $20) is measured. Foods used were considered unhealthy snack foods, e.g. cookies, potato chips, etc. Intensity, the number of portions of food requested when the price is $0, was used as the outcome measure. Significant non-normality of the data required a log base 10 transformation (log (food portions + 1). Larger numbers represent more food portions, higher intensity and higher reinforcing efficacy. Change is assessed using repeated measures.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking (EFT) n=31 Participants Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 Participants Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Changes in Relative Reinforcing Efficacy of Unhealthy Food Baseline relative reinforcing efficacy of unhealthy food	0.926 log (food portions + 1) Standard Deviation 0.483	0.998 log (food portions + 1) Standard Deviation 0.375
Changes in Relative Reinforcing Efficacy of Unhealthy Food Change from baseline in relative reinforcing efficacy of unhealthy food at 12 weeks	-0.351 log (food portions + 1) Standard Deviation 0.466	-0.348 log (food portions + 1) Standard Deviation 0.442
Changes in Relative Reinforcing Efficacy of Unhealthy Food Change from baseline in relative reinforcing efficacy of unhealthy food at 24 weeks.	-0.328 log (food portions + 1) Standard Deviation 0.545	-0.247 log (food portions + 1) Standard Deviation 0.468

Adverse Events

Episodic Future Thinking (EFT)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Daily Check in (DCI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Episodic Future Thinking (EFT) n=31 participants at risk Participants will generate positive future cues that will be accessed via an electronic app to engage in EFT. Episodic Future Thinking: Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.	Daily Check in (DCI) n=33 participants at risk Participants will be asked to access an electronic app daily, but will receive no cues. Daily Check in: Participants will be asked to access the electronic app at the same rate as the experimental group (e.g. daily). Participants will receive behavioral weight loss treatment including The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, and finding behavioral substitutes for highly reinforcing food.
Eye disorders Torn Retina	3.2% 1/31 • Number of events 1 • 24 weeks	0.00% 0/33 • 24 weeks

Other adverse events

Adverse event data not reported

Additional Information

Leonard H. Epstein

University at Buffalo

Phone: 716-829-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place