Behavioral Mechanism of Energy Compensation With Exercise

NCT04651218 | Completed Phase 3 Results

• 2 other identifiers: 52127P30GM127211
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Weight Loss; Eating Behavior

Keywords

attentional bias; inhibitory control; food reinforcement; energy compensation; exercise

Outcome Measures

Primary Outcomes (12)

• Attentional Bias

  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

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

• Attentional Bias

  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.

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

• Attentional Bias

  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.

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

• Attentional Bias

  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.

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

• Inhibitory Control

  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)

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

• Inhibitory Control

  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)

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

• Inhibitory Control

  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)

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

• Inhibitory Control

  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)

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

• Food Reinforcement

  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

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

• Food Reinforcement

  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

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

• Food Reinforcement

  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

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

• Food Reinforcement

  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

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

Study Arms (2)

control

NO INTERVENTION

sedentary control group watches TV between being assessed for outcome measures

exercise

EXPERIMENTAL

exercise treatment performs exercise between being assessed for outcome measures

Behavioral: exericse

Interventions

exericse BEHAVIORAL

participants perform aerobic exercise until they expend 500 kcal

exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• overweight to obese (BMI 25-45 kg/m2)
• not currently engaged in exercise or weight loss activities
• free of any cardiac, pulmonary, or metabolic health conditions
• able to safely engage in exercise
• female participants must be premenopausal and not pregnant or nursing.

You may not qualify if:

• Lost or gained over 5% of their current bodyweight in the previous 12 months.
• taking any medications or dietary supplements which may influence energy expenditure or intake
• have not been diagnosed with an eating disorder, clinical depression, or an anxiety disorder
• engage in less than 150 minutes of moderate to vigorous physical activity per week (assessed via accelerometry at baseline)

Sponsors & Collaborators

• Kyle Flack: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Kentucky- Nutrition Assessment Lab

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Feeding Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior, Animal; Behavior

Limitations and Caveats

We originally desired to recruit 30 males and 30 females (60 total). However we were only able to recruit 32 individuals due to time constraints with sponsor. This limits out power in detecting sex differences, but does not the overall findings of the study.

Results Point of Contact

• Title: Dr. Kyle Flack
• Organization: University of Kentucky

kyle.flack@uky.edu

5182574351

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking true propose of study- assessing eating behaviors.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: counter balanced crossover design, exercise group and control treatment.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 3, 2020
• Study Start: February 9, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 7, 2022
• Last Updated: January 4, 2023
• Results First Posted: December 29, 2022

Record last verified: 2022-12

Locations

US (1)