Trial Outcomes & Findings for Behavioral Mechanism of Energy Compensation With Exercise (NCT NCT04651218)

Results Overview

The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen \[80-82\]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Outcome measure: percentage of time fixated on food cues.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

32 participants

Primary outcome timeframe

15 minutes after the bout of television watching on the day the participant completed the non-exercise / control arm

Results posted on

2023-01-04

Participant Flow

Recruitment started February 1st, 2021, first participant enrolled February 9th, 2021. Study remained open to recruitment through November 2021. Recruitment efforts included study advertisements primarily on Facebook or the University of Kentucky Center for Clinical and Translational Science current study webpage.

Participants were initially enrolled only if they met eligibility criteria. Upon enrollment, participants wore an accelerometer for 7 days to measure their daily physical activity. If participants accumulated more than 90 minutes of vigorous physical activity per week, they were excluded before group assignment. No participant was excluded for this criteria.

Participant milestones

Participant milestones
Measure	Control First, Then Exercise Arm sedentary control group watches TV between being assessed for outcome measures exercise treatment performs exercise between being assessed for outcome measures exercise: participants perform aerobic exercise until they expend 500 kcal	Exercise Arm First, Then Control exercise treatment performs exercise between being assessed for outcome measures exercise: participants perform aerobic exercise until they expend 500 kcal sedentary control group watches TV between being assessed for outcome measures
Overall Study STARTED	16	16
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control First, Then Exercise Arm sedentary control group watches TV between being assessed for outcome measures exercise treatment performs exercise between being assessed for outcome measures exercise: participants perform aerobic exercise until they expend 500 kcal	Exercise Arm First, Then Control exercise treatment performs exercise between being assessed for outcome measures exercise: participants perform aerobic exercise until they expend 500 kcal sedentary control group watches TV between being assessed for outcome measures
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=32 Participants All participants completed both arms- exercise and sedentary
Age, Categorical <=18 years	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants
Age, Categorical >=65 years	0 Participants n=32 Participants
Sex: Female, Male Female	15 Participants n=32 Participants
Sex: Female, Male Male	17 Participants n=32 Participants
Vigorous Physical Activity	5.103 Minutes STANDARD_DEVIATION 13.71 • n=32 Participants • Assessment of habitual physical activity was taken between visits one and two, prior to completion of an outcome test. Visit 1: provide accelerometer, visit 2: collect accelerometer and record data. Data collected prior to visit 2.
BMI	32.67 kg/m^2 STANDARD_DEVIATION 5.16 • n=32 Participants
Percent Body Fat	38.52 percentage STANDARD_DEVIATION 7.99 • n=32 Participants

PRIMARY outcome

Timeframe: Immediately prior to exercise bout on the day the participant completed the exercise arm

Population: Prior to exercise bout timepoint was not performed in control group

The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen \[80-82\]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Outcome measure: percentage of time fixated on food cues

Outcome measures

Outcome measures
Measure	Control sedentary control group watches TV between being assessed for outcome measures	Exercise n=30 Participants exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Attentional Bias	—	48.85 percentage of time fixated on food cues Standard Error 1.51

PRIMARY outcome

Timeframe: Immediately prior to bout of television watching on the day the participant completed the non-exercise / control arm

Population: prior to bout of television time point was only performed when participants partook in control arm

The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen \[80-82\]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Outcome measure: percentage of time fixated on food cues.

Outcome measures

Outcome measures
Measure	Control n=30 Participants sedentary control group watches TV between being assessed for outcome measures	Exercise exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Attentional Bias	50.81 percentage of time fixated on food cues Standard Error 1.22	—

PRIMARY outcome

Timeframe: 15 minutes after the bout of television watching on the day the participant completed the non-exercise / control arm

Population: after bout of television watching timepoint was only completed when participants completed control arm

The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen \[80-82\]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Outcome measure: percentage of time fixated on food cues.

Outcome measures

Outcome measures
Measure	Control n=30 Participants sedentary control group watches TV between being assessed for outcome measures	Exercise exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Attentional Bias	50.15 percentage of time fixated on food cues Standard Error 1.68	—

PRIMARY outcome

Timeframe: 15 minutes after the exercise bout on the day the participant completed the exercise arm

Population: after bout of exercise timepoint was only completed when participants completed exercise arm

The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen \[80-82\]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Primary outcome measure: percentage of time fixated on food cues.

Outcome measures

Outcome measures
Measure	Control sedentary control group watches TV between being assessed for outcome measures	Exercise n=30 Participants exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Attentional Bias	—	55.24 percentage of time fixated on food cues Standard Error 1.09

PRIMARY outcome

Timeframe: Immediately prior to exercise bout on the day the participant completed the exercise arm

Population: prior to bout of exercise timepoint was only completed when participants completed exercise arm

Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues. Main outcome measure: percentage of inhibitory fails (pressing button when presented with a blue cue after a food image is presented)

Outcome measures

Outcome measures
Measure	Control sedentary control group watches TV between being assessed for outcome measures	Exercise n=30 Participants exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Inhibitory Control	—	8.67 percentage of incorrect responses Standard Error 2.0

PRIMARY outcome

Timeframe: Immediately prior to bout of television watching on the day the participant completed the non-exercise / control arm

Population: prior to bout of television watching timepoint was only completed when participants completed control arm

Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues. Main outcome measure: percentage of inhibitory fails (pressing button when presented with a blue cue after a food image is presented)

Outcome measures

Outcome measures
Measure	Control n=30 Participants sedentary control group watches TV between being assessed for outcome measures	Exercise exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Inhibitory Control	10.40 percentage of incorrect responses Standard Error 2.4	—

PRIMARY outcome

Timeframe: 15 minutes after the exercise bout on the day the participant completed the exercise arm

Population: after bout of exercise timepoint was only completed when participants completed exercise arm

Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues. Main outcome measure: percentage of inhibitory fails (pressing button when presented with a blue cue after a food image is presented)

Outcome measures

Outcome measures
Measure	Control sedentary control group watches TV between being assessed for outcome measures	Exercise n=30 Participants exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Inhibitory Control	—	11.73 percentage of incorrect responses Standard Error 2.8

PRIMARY outcome

Timeframe: 15 minutes after the bout of television watching on the day the participant completed the non-exercise / control arm

Population: after bout of television watching timepoint was only completed when participants completed control arm

Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues. Main outcome measure: percentage of inhibitory fails (pressing button when presented with a blue cue after a food image is presented)

Outcome measures

Outcome measures
Measure	Control n=30 Participants sedentary control group watches TV between being assessed for outcome measures	Exercise exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Inhibitory Control	13.87 percentage of incorrect responses Standard Error 2.9	—

PRIMARY outcome

Timeframe: Immediately prior to exercise bout on the day the participant completed the exercise arm

Population: Prior to exercise bout timepoint was only completed when participants completed the exercise condition

Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item "on auction". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion of the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued

Outcome measures

Outcome measures
Measure	Control sedentary control group watches TV between being assessed for outcome measures	Exercise n=30 Participants exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Food Reinforcement	—	1.78 Dollars Standard Error 1.6

PRIMARY outcome

Timeframe: Immediately prior to bout of television watching on the day the participant completed the non-exercise / control arm

Population: Prior to Television watching timepoint was only completed when participants completed the control condition

Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item "on auction". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion of the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued

Outcome measures

Outcome measures
Measure	Control n=30 Participants sedentary control group watches TV between being assessed for outcome measures	Exercise exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Food Reinforcement	1.84 Dollars Standard Error 1.62	—

PRIMARY outcome

Timeframe: 15 minutes after the exercise bout on the day the participant completed the exercise arm

Population: after exercise bout timepoint was only completed when participants completed the exercise condition

Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item "on auction". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion of the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued

Outcome measures

Outcome measures
Measure	Control sedentary control group watches TV between being assessed for outcome measures	Exercise n=30 Participants exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Food Reinforcement	—	1.71 Dollars Standard Error 1.60

PRIMARY outcome

Timeframe: 15 minutes after the bout of television watching on the day the participant completed the non-exercise / control arm

Population: after watching television timepoint was only completed when participants completed the control condition

Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item "on auction". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion of the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued

Outcome measures

Outcome measures
Measure	Control n=30 Participants sedentary control group watches TV between being assessed for outcome measures	Exercise exercise treatment performs exercise between being assessed for outcome measures exericse: participants perform aerobic exercise until they expend 500 kcal
Food Reinforcement	1.89 Dollars Standard Error 1.65	—

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise

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. Kyle Flack

University of Kentucky

Phone: 5182574351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place