Motivation to Exercise (Motiv2Ex)
Primary Purpose
Overweight, Obesity, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Dose Exercise (300 kcal)
Low Dose Exercise (150 kcal)
No Exercise (0 kcal)
Sedentary Option
Sponsored by
About this trial
This is an interventional other trial for Overweight
Eligibility 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
Sites / Locations
- USDA Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
High Dose Exercise vs Sedentary Option
Low Dose Exercise vs Sedentary Option
No Exercise vs Sedentary Option
Arm Description
Relative Reinforcing Value of high dose exercise (300 kcal expenditure per session) versus sedentary activity will be determined.
Relative Reinforcing Value of low dose exercise (150 kcal expenditure per session) versus sedentary activity will be determined.
Relative Reinforcing Value of no exercise (0 kcal expenditure per session) versus sedentary activity will be determined.
Outcomes
Primary Outcome Measures
Change in relative reinforcing value (RRV) of physical activity
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.
Changes in preference for intense physical activity and tolerance for exercise discomfort
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).
Secondary Outcome Measures
Change in minutes of physical activity, as assessed by activity tracker
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.
Changes in perceived support for physical activity from friends and family members
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.
Changes in perceptions of how much exercise satisfies autonomy, relatedness, and competence needs
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.
Changes in intrinsic, external, interrogated, identified, introjected and amotivation for physical activity
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).
Changes in perceived effort expended during exercise
Changes in perceived effort expended during exercise will be assessed by self-report questionnaire responses to the Rating of Perceived Exertion Scale.
Changes in perceived pain/discomfort during exercise
Changes in perceived pain/discomfort during exercise will be assessed by self-report questionnaire responses to the Muscle Pain Questionnaire.
Changes in perceived ability to continue exercise long-term
Changes in perceived ability to continue exercise long-term will be assessed by self-report questionnaire responses to the Exercise Self-Efficacy Scale.
Changes in perceived ability to stick to an exercise routine
Changes in perceived ability to stick to an exercise routine will be assessed by self-report questionnaire responses to the Exercise Confidence Survey.
Changes in perceived affective responses to exercise
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).
Changes in average daily caloric intake
Changes in average daily calorie intake will be assessed by reporting all foods and beverages consumed over a 3-day period.
Full Information
NCT ID
NCT02444247
First Posted
May 7, 2015
Last Updated
August 9, 2019
Sponsor
USDA Grand Forks Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02444247
Brief Title
Motivation to Exercise
Acronym
Motiv2Ex
Official Title
Motivation to Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to understand how to make exercise more attractive to people.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Physical Activity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Exercise vs Sedentary Option
Arm Type
Other
Arm Description
Relative Reinforcing Value of high dose exercise (300 kcal expenditure per session) versus sedentary activity will be determined.
Arm Title
Low Dose Exercise vs Sedentary Option
Arm Type
Other
Arm Description
Relative Reinforcing Value of low dose exercise (150 kcal expenditure per session) versus sedentary activity will be determined.
Arm Title
No Exercise vs Sedentary Option
Arm Type
Other
Arm Description
Relative Reinforcing Value of no exercise (0 kcal expenditure per session) versus sedentary activity will be determined.
Intervention Type
Other
Intervention Name(s)
High Dose Exercise (300 kcal)
Intervention Description
Subjects will participate in 3 physical activity sessions per week expending 300 kcal per session and rate their liking of exercise.
Intervention Type
Other
Intervention Name(s)
Low Dose Exercise (150 kcal)
Intervention Description
Subjects will participate in 3 physical activity sessions per week expending 150 kcal per session and rate their liking of exercise.
Intervention Type
Other
Intervention Name(s)
No Exercise (0 kcal)
Intervention Description
Subjects will participate in 3 sessions per week expending 0 kcal per session and rate their liking of exercise.
Intervention Type
Other
Intervention Name(s)
Sedentary Option
Intervention Description
Subjects will rate their liking of sedentary activities (reading magazines, playing word games, puzzles) as an alternative to exercise.
Primary Outcome Measure Information:
Title
Change in relative reinforcing value (RRV) of physical activity
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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in preference for intense physical activity and tolerance for exercise discomfort
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).
Time Frame
Week 0, Week 6, Week 10
Secondary Outcome Measure Information:
Title
Change in minutes of physical activity, as assessed by activity tracker
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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in perceived support for physical activity from friends and family members
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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in perceptions of how much exercise satisfies autonomy, relatedness, and competence needs
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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in intrinsic, external, interrogated, identified, introjected and amotivation for physical activity
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).
Time Frame
Week 0, Week 6, Week 10
Title
Changes in perceived effort expended during exercise
Description
Changes in perceived effort expended during exercise will be assessed by self-report questionnaire responses to the Rating of Perceived Exertion Scale.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in perceived pain/discomfort during exercise
Description
Changes in perceived pain/discomfort during exercise will be assessed by self-report questionnaire responses to the Muscle Pain Questionnaire.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in perceived ability to continue exercise long-term
Description
Changes in perceived ability to continue exercise long-term will be assessed by self-report questionnaire responses to the Exercise Self-Efficacy Scale.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in perceived ability to stick to an exercise routine
Description
Changes in perceived ability to stick to an exercise routine will be assessed by self-report questionnaire responses to the Exercise Confidence Survey.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in perceived affective responses to exercise
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).
Time Frame
Week 0, Week 6, Week 10
Title
Changes in average daily caloric intake
Description
Changes in average daily calorie intake will be assessed by reporting all foods and beverages consumed over a 3-day period.
Time Frame
Week 0, Week 6, Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James N Roemmich, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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