Expired Study
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Grand Forks, North Dakota 58203


Purpose:

The purpose of this study is to understand how to make exercise more attractive to people.


Study summary:

This investigation will address increased physical activity and will yield empirical evidence to inform developing tools to help individuals make healthy choices regarding physical activity (PA) and maintenance of healthy body weight. Behavioral Choice Theory provides a framework for understanding choices people make and how to shift an individual's choice toward healthier alternatives. The theory holds that choice is based on the relative motivating values of alternatives. One way to shift choice toward a healthier alternative is to increase the relative reinforcing value (RRV), or motivating value, of that alternative. Thus, increasing the RRV of PA behaviors could shift choice towards PA and away from less healthy, sedentary alternatives. Increasing the RRV of PA may allow PA to compete with more reinforcing, sedentary behaviors, resulting in a shift in behavioral choice. This process is termed "incentive sensitization", which was originally proposed to explain drug addiction. Incentive Sensitization theory posits that the RRV of a behavior is increased through repeated exposures, which produce neuroadaptations that increase craving of the behavior - after repeated exposures to a stimulus, a 'sensitization' or hypersensitivity to the incentive motivational effects of the stimulus follows. Another factor that influences motivation for a behavior is the development of tolerance to unpleasant aspects of that behavior. Opponent-Process Theory would account for the acquisition of motives where the initial reinforcer may be negative - the affect experienced after repeated exposures is opposite to that experienced during the first few presentations. For exercise, this would include tolerance to any discomfort, pain, fatigue and displeasure and a greater positive post-exercise affective response: the affect experienced during and after exercise has a greater motivational significance in PA participation than knowledge and beliefs regarding health benefits. Therefore, the investigators propose that repeated exposures to PA will produce tolerance to unpleasant aspects while increasing the post-exercise affect. Sensitizing PA reinforcement and increasing discomfort tolerance may be associated with increasing the duration and intensity of daily activity. There are likely to be individual differences in sensitization of PA reinforcement and development of discomfort tolerance. Single-nucleotide polymorphisms (SNPs) that alter dopamine tone in the central dopaminergic reward system and SNPs associated with altered pain perception may contribute to such individual differences. The investigators anticipate that a moderate PA dose (300 kilocalorie [kcal] expenditure) will produce greater incentive sensitization and tolerance than a low dose (150 kcal) and that SNPs related to central dopamine tone and pain perception may contribute to individual differences in incentive sensitization and changes in physical activity after repeated exposures to physical activity.


Criteria:

Inclusion Criteria: - BMI within 19-35 kg/m2 - Healthy enough to exercise - Sedentary (not regularly engaging in exercise more than once per week) Exclusion Criteria: - Taking any medications that affect energy expenditure or eating - Have gained or lost more than 10 pounds over the past 3 months - Use tobacco - Pregnant or lactating or plan to become pregnant in the next 6 months - Have any medical conditions that prevent the individual from safely joining in physical activity - Have high work-related activity such as construction and farm work


Study is Available At:


Original ID:

GFHNRC400


NCT ID:

NCT02444247


Secondary ID:


Study Acronym:

Motiv2Ex


Brief Title:

Motivation to Exercise


Official Title:

Motivation to Exercise


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

49 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

USDA Grand Forks Human Nutrition Research Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

93


Enrollment Type:

Actual


Overall Contact Information

Official Name:James N Roemmich, PhD
Principal Investigator
USDA Grand Forks Human Nutrition Research Center

Study Dates

Start Date:June 2015
Completion Date:February 2017
Completion Type:Actual
Primary Completion Date:February 2017
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 9, 2019
First Received Date:May 7, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes in average daily caloric intake
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in average daily calorie intake will be assessed by reporting all foods and beverages consumed over a 3-day period.
Outcome Type:Secondary Outcome
Measure:Changes in perceived affective responses to exercise
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in perceived affective responses (energy, tiredness, tension, calmness) to exercise will be assessed by self-report questionnaire responses to the Activation Deactivation Adjective Check List (ADCL).
Outcome Type:Secondary Outcome
Measure:Changes in perceived ability to stick to an exercise routine
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in perceived ability to stick to an exercise routine will be assessed by self-report questionnaire responses to the Exercise Confidence Survey.
Outcome Type:Secondary Outcome
Measure:Changes in perceived ability to continue exercise long-term
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in perceived ability to continue exercise long-term will be assessed by self-report questionnaire responses to the Exercise Self-Efficacy Scale.
Outcome Type:Secondary Outcome
Measure:Changes in perceived pain/discomfort during exercise
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in perceived pain/discomfort during exercise will be assessed by self-report questionnaire responses to the Muscle Pain Questionnaire.
Outcome Type:Secondary Outcome
Measure:Changes in perceived effort expended during exercise
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in perceived effort expended during exercise will be assessed by self-report questionnaire responses to the Rating of Perceived Exertion Scale.
Outcome Type:Secondary Outcome
Measure:Changes in intrinsic, external, interrogated, identified, introjected and amotivation for physical activity
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in intrinsic, external, interrogated, identified, introjected and amotivation for physical activity will be assessed by self-report questionnaire responses to the Behavioral Regulation in Exercise, 3rd Edition (BREQ-3).
Outcome Type:Secondary Outcome
Measure:Changes in perceptions of how much exercise satisfies autonomy, relatedness, and competence needs
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in perceptions of how much exercise satisfies autonomy, relatedness, and competence needs will be assessed by self-report questionnaire responses to the Psychological Need Satisfaction in Exercise Scale.
Outcome Type:Secondary Outcome
Measure:Changes in perceived support for physical activity from friends and family members
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes perceived support for physical activity from friends and family members will be assessed by self-report questionnaire responses to the Social Norms and Support for Exercise Questionnaire.
Outcome Type:Secondary Outcome
Measure:Change in minutes of physical activity, as assessed by activity tracker
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Minutes of physical activity will be assessed by having participants wear an Actigraph accelerometer for 7 days (minimum 10 hours per day) on the right hip.
Outcome Type:Primary Outcome
Measure:Changes in preference for intense physical activity and tolerance for exercise discomfort
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:Changes in preference for intense physical activity and tolerance for exercise discomfort will be assessed by self-report questionnaire responses to the Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q).
Outcome Type:Primary Outcome
Measure:Change in relative reinforcing value (RRV) of physical activity
Time Frame:Week 0, Week 6, Week 10
Safety Issues:False
Description:RRV of physical activity will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to physical activity or a sedentary alternative.

Study Interventions

Intervention Type:Other
Name:High Dose Exercise (300 kcal)
Description:Subjects will participate in 3 physical activity sessions per week expending 300 kcal per session and rate their liking of exercise.
Arm Name:High Dose Exercise vs Sedentary Option
Intervention Type:Other
Name:Low Dose Exercise (150 kcal)
Description:Subjects will participate in 3 physical activity sessions per week expending 150 kcal per session and rate their liking of exercise.
Arm Name:Low Dose Exercise vs Sedentary Option
Intervention Type:Other
Name:No Exercise (0 kcal)
Description:Subjects will participate in 3 sessions per week expending 0 kcal per session and rate their liking of exercise.
Arm Name:No Exercise vs Sedentary Option
Intervention Type:Other
Name:Sedentary Option
Description:Subjects will rate their liking of sedentary activities (reading magazines, playing word games, puzzles) as an alternative to exercise.
Arm Name:High Dose Exercise vs Sedentary Option

Study Arms

Study Arm Type:Other
Arm Name:High Dose Exercise vs Sedentary Option
Description:Relative Reinforcing Value of high dose exercise (300 kcal expenditure per session) versus sedentary activity will be determined.
Study Arm Type:Other
Arm Name:Low Dose Exercise vs Sedentary Option
Description:Relative Reinforcing Value of low dose exercise (150 kcal expenditure per session) versus sedentary activity will be determined.
Study Arm Type:Other
Arm Name:No Exercise vs Sedentary Option
Description:Relative Reinforcing Value of no exercise (0 kcal expenditure per session) versus sedentary activity will be determined.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:USDA Grand Forks Human Nutrition Research Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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