OverweightMotiv2ExNCT02444247
Motivation to Exercise
A study testing High Dose Exercise (300 kcal), Low Dose Exercise (150 kcal) and No Exercise (0 kcal) in people with Overweight and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to understand how to make exercise more attractive to people. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Physical Activity
- What is being tested?
- High Dose Exercise (300 kcal), Low Dose Exercise (150 kcal) and No Exercise (0 kcal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI within 19-35 kg/m2
- Healthy enough to exercise
- Sedentary (not regularly engaging in exercise more than once per week)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
The purpose of this study is to understand how to make exercise more attractive to people.
Read the 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.
- Conditions
- Overweight, Obesity, Physical Activity
- Being tested
- High Dose Exercise (300 kcal), Low Dose Exercise (150 kcal), No Exercise (0 kcal), Sedentary Option
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Exercise (300 kcal)Other
Subjects will participate in 3 physical activity sessions per week expending 300 kcal per session and rate their liking of exercise.
Low Dose Exercise (150 kcal)Other
Subjects will participate in 3 physical activity sessions per week expending 150 kcal per session and rate their liking of exercise.
No Exercise (0 kcal)Other
Subjects will participate in 3 sessions per week expending 0 kcal per session and rate their liking of exercise.
Sedentary OptionOther
Subjects will rate their liking of sedentary activities (reading magazines, playing word games, puzzles) as an alternative to exercise.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Exercise vs Sedentary Option | Other | Relative Reinforcing Value of high dose exercise (300 kcal expenditure per session) versus sedentary activity will be determined. Receives: Other: High Dose Exercise (300 kcal); Other: Sedentary Option |
| Low Dose Exercise vs Sedentary Option | Other | Relative Reinforcing Value of low dose exercise (150 kcal expenditure per session) versus sedentary activity will be determined. Receives: Other: Low Dose Exercise (150 kcal); Other: Sedentary Option |
| No Exercise vs Sedentary Option | Other | Relative Reinforcing Value of no exercise (0 kcal expenditure per session) versus sedentary activity will be determined. Receives: Other: No Exercise (0 kcal); Other: Sedentary Option |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, Week 6, Week 10
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).
Measured: Week 0, Week 6, Week 10
Secondary outcomes (10)
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.
Measured: Week 0, Week 6, Week 10
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.
Measured: Week 0, Week 6, Week 10
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.
Measured: Week 0, Week 6, Week 10
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).
Measured: Week 0, Week 6, Week 10
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.
Measured: Week 0, Week 6, Week 10
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.
Measured: Week 0, Week 6, Week 10
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.
Measured: Week 0, Week 6, Week 10
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.
Measured: Week 0, Week 6, Week 10
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).
Measured: Week 0, Week 6, Week 10
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.
Measured: Week 0, Week 6, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James N Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444247
- Sponsor's protocol ID
- GFHNRC400
- Acronym
- Motiv2Ex
- Status last verified
- Apr 2025
- First submitted
- 7 May 2015
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation to Exercise
- ClinicalTrials.gov ID
- NCT02444247
- Acronym / sponsor ID
- Motiv2Ex / GFHNRC400
- Conditions
- Overweight, Obesity, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Exercise vs Sedentary Option | Other | Other: High Dose Exercise (300 kcal), Other: Sedentary OptionRelative Reinforcing Value of high dose exercise (300 kcal expenditure per session) versus sedentary activity will be determined. |
| Low Dose Exercise vs Sedentary Option | Other | Other: Low Dose Exercise (150 kcal), Other: Sedentary OptionRelative Reinforcing Value of low dose exercise (150 kcal expenditure per session) versus sedentary activity will be determined. |
| No Exercise vs Sedentary Option | Other | Other: No Exercise (0 kcal), Other: Sedentary OptionRelative Reinforcing Value of no exercise (0 kcal expenditure per session) versus sedentary activity will be determined. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI within 19-35 kg/m2
- Healthy enough to exercise
- Sedentary (not regularly engaging in exercise more than once per week)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Exercise (300 kcal)Subjects will participate in 3 physical activity sessions per week expending 300 kcal per session and rate their liking of exercise. | Other | High Dose Exercise vs Sedentary Option |
| Low Dose Exercise (150 kcal)Subjects will participate in 3 physical activity sessions per week expending 150 kcal per session and rate their liking of exercise. | Other | Low Dose Exercise vs Sedentary Option |
| No Exercise (0 kcal)Subjects will participate in 3 sessions per week expending 0 kcal per session and rate their liking of exercise. | Other | No Exercise vs Sedentary Option |
| Sedentary OptionSubjects will rate their liking of sedentary activities (reading magazines, playing word games, puzzles) as an alternative to exercise. | Other | High Dose Exercise vs Sedentary Option, Low Dose Exercise vs Sedentary Option, No Exercise vs Sedentary Option |
Primary outcome
Change in relative reinforcing value (RRV) of physical activity
Time frame: Week 0, Week 6, Week 10
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
Time frame: Week 0, Week 6, Week 10
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).
10 secondary outcomes
Change in minutes of physical activity, as assessed by activity tracker
Time frame: Week 0, Week 6, Week 10
Changes in perceived support for physical activity from friends and family members
Time frame: Week 0, Week 6, Week 10
Changes in perceptions of how much exercise satisfies autonomy, relatedness, and competence needs
Time frame: Week 0, Week 6, Week 10
Changes in intrinsic, external, interrogated, identified, introjected and amotivation for physical activity
Time frame: Week 0, Week 6, Week 10
Changes in perceived effort expended during exercise
Time frame: Week 0, Week 6, Week 10
Changes in perceived pain/discomfort during exercise
Time frame: Week 0, Week 6, Week 10
Changes in perceived ability to continue exercise long-term
Time frame: Week 0, Week 6, Week 10
Changes in perceived ability to stick to an exercise routine
Time frame: Week 0, Week 6, Week 10
Changes in perceived affective responses to exercise
Time frame: Week 0, Week 6, Week 10
Changes in average daily caloric intake
Time frame: Week 0, Week 6, Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James N Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Exercise (300 kcal), Low Dose Exercise (150 kcal) and No Exercise (0 kcal) in people with Overweight and Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relative reinforcing value (RRV) of physical activity (time frame: Week 0, Week 6, Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.