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NCT04651218

Behavioral Mechanism of Energy Compensation With Exercise

Completed Phase 3 Results posted Last updated 4 January 2023
What this trial tests

Phase 3 trial testing exericse in Obesity in 32 participants. Completed in 7 December 2022.

Timeline
9 February 2021
Primary endpoint
30 November 2021
7 December 2022

Quick facts

Lead sponsorKyle Flack
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment32
Start date9 February 2021
Primary completion30 November 2021
Estimated completion7 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Kyle Flack

Who can join

Adults 18 to 45, any sex, with Obesity or Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Attentional Bias Primary · Immediately prior to exercise bout on the day the participant completed the 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. Out

GroupValue95% CI
Exercise48.85± 1.51
Attentional Bias Primary · Immediately prior to bout of television watching on the day the participant completed the non-exercise / 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. Out

GroupValue95% CI
Control50.81± 1.22
Attentional Bias Primary · 15 minutes after the bout of television watching on the day the participant completed the non-exercise / 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. Out

GroupValue95% CI
Control50.15± 1.68
Attentional Bias Primary · 15 minutes after the exercise bout on the day the participant completed the 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. Pri

GroupValue95% CI
Exercise55.24± 1.09
Inhibitory Control Primary · Immediately prior to exercise bout on the day the participant completed the 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 w

GroupValue95% CI
Exercise8.67± 2.0
Inhibitory Control Primary · Immediately prior to bout of television watching on the day the participant completed the non-exercise / 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 w

GroupValue95% CI
Control10.40± 2.4
Inhibitory Control Primary · 15 minutes after the exercise bout on the day the participant completed the 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 w

GroupValue95% CI
Exercise11.73± 2.8
Inhibitory Control Primary · 15 minutes after the bout of television watching on the day the participant completed the non-exercise / 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 w

GroupValue95% CI
Control13.87± 2.9
Food Reinforcement Primary · Immediately prior to exercise bout on the day the participant completed the exercise arm

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 opt

GroupValue95% CI
Exercise1.78± 1.6
Food Reinforcement Primary · Immediately prior to bout of television watching on the day the participant completed the non-exercise / control arm

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 opt

GroupValue95% CI
Control1.84± 1.62
Food Reinforcement Primary · 15 minutes after the exercise bout on the day the participant completed the exercise arm

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 opt

GroupValue95% CI
Exercise1.71± 1.60
Food Reinforcement Primary · 15 minutes after the bout of television watching on the day the participant completed the non-exercise / control arm

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 opt

GroupValue95% CI
Control1.89± 1.65

Sponsor's own description

Over 70% of Americans are either overweight or obese, putting them at risk for many chronic diseases including diabetes. Exercise is commonly used as a weight loss and weight loss maintenance strategy. However, exercise-induced weight loss is often much less than expected as individuals compensate for a large portion of the energy expended through exercise, resisting maintenance of the negative energy balance needed for weight loss. Our prior research, in agreement with others, point to increases in energy intake as the primary compensatory response when exercising for weight loss; however, mechanisms promoting this behavior have yet to be fully elucidated. With obesity and diabetes prevalence continually rising, innovative research is needed to identify novel mechanisms promoting energy compensation with exercise. The long-term goal of this proposal is to reduce the incidence and improve the outcomes of obesity-related diseases by developing interventions that will attenuate compensation for the energy expended through exercise and thus improve initial weight loss and weight loss maintenance. The present proposal will take the necessary first steps towards our long-term goal by identifying novel mechanisms promoting energy intake when exercising for weight loss. One's reinforcing value of food, attentional bias and inhibitory control for food cues play an important role in feeding behaviors, independent of hunger. These behaviors are largely a product of the central dopamine reward system, which is also in play with exercise behavior. This provides mechanistic support for our central hypothesis, that exercise evokes increases in food reinforcement, attentional bias, and lowers inhibitory control for food cues to promote greater energy intake in effort to maintain energy homeostasis. The rationale for this project is by elucidating the mechanisms mediating energy compensation, future interventions can be designed that attenuate this response to improve the utility of exercise as a weight loss intervention to prevent and manage T2DM. The overall objective of the current proposal is to demonstrate an acute bout of exercise alters food reinforcement, attentional bias and inhibitory control for food cues. Upon completion, we will have a greater understanding of the mechanisms underpinning compensatory increases in energy intake when exercising. These findings will pave the way for future clinical trials testing this hypothesis in the context of a long-term exercise intervention. This contribution is significant, as the identification of novel mechanisms influencing energy compensation with exercise is needed to provide strong support for the development of novel, evidence-based interventions to attenuate this compensatory response to exercise, improving its efficacy for weight control and chronic disease management.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Characterizing motor impulsivity of individuals classified as overweight to obese.
    Flack KD, Anderson Iii RE, McFee KF, Day BT. · · 2023 · cited 2× · PMID 38314047 · DOI 10.1016/j.smhs.2023.08.003

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