OverweightNCT03162978
Sprint to Fitness: Effect of Outcome Expectations on Responses to Interval Exercise Training
A study testing HIIT + POE and HIIT only 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 research the effects of exercising at high intensities for short periods of time on exercise tolerance and motivation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- HIIT + POE and HIIT only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 21 Oct 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index of 25-35 kg/m2
- Sedentary (not regularly engaging in exercise more than once per week)
- Weight stable (have not lost or gained over 10 pounds of body weight in the past 3 months)
Who cannot join
- Taking any medications that affect energy expenditure or treat high blood pressure
- Tobacco use
- Pregnant or breastfeeding or plan to become pregnant in the next 3 months
- Have any medical conditions that prevent subject from safely exercising (e.g., orthopedic injuries, cardiovascular, liver, endocrine, or pulmonary diseases)
- Resting systolic blood pressure ≥ 140 mmHg
- Resting diastolic blood pressure ≥ 90 mmHg
- Non-fasting plasma glucose of ≥ 200 mg/dl
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
Official title: Effect of Outcome Expectations on Psychological and Physiological Responses to Interval Exercise Training
The purpose of this study is to research the effects of exercising at high intensities for short periods of time on exercise tolerance and motivation.
Read the detailed description
The proposed research will investigate whether adding a treatment component that focuses on positive outcome expectations of a high-intensity interval training (HIIT) intervention produces greater improvements in psychological and physiological study outcomes. This project will yield empirical evidence that will inform how to help Americans meet physical activity guidelines; how to develop exercise programs that are more likely to promote exercise as a habit; and maintenance of health and a healthy body weight.
- Conditions
- Overweight, Obesity
- Being tested
- HIIT + POE, HIIT only
- Keywords
- Exercise, behavior economics
- 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.
HIIT + POEOther
Subjects will participate in high-intensity interval training (HIIT) with an additional treatment component to increase positive outcome expectations (POE) of exercise.
HIIT onlyOther
Subjects will participate in high-intensity interval training (HIIT) only.
| Study group | Role | What they receive |
|---|---|---|
| HIIT + POE | Experimental | High-intensity interval training (HIIT) plus positive outcome expectations (POE) from participating in the exercise program. Receives: Other: HIIT + POE |
| HIIT only | Experimental | High-intensity interval training (HIIT) only. Receives: Other: HIIT only |
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). The PRETIE-Q measures preference for high intensity vs. low intensity exercise and ability to persist or tolerate the discomfort associationed with intense exercise. The PRETIE-Q consists of two subscales: Preference for Exercise Intensity and Tolerance of Exercise Intensity. Each subscale has 8 items rated on a 5 point response scale (range 8 - 40). Higher scores indicate greater preference for intense exercise and/or greater tolerance for exercise discomfort. Total scale scores are not used. Scale averages will be used.
Measured: Week 0, Week 6, Week 10
Secondary outcomes (15)
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 quadriceps and hamstring (thigh muscle) strength assessed separately on each leg
After range of motion is determined, participants will engage in a series of extensions and flexions in which maximum velocity is set at 60°, 180°, and 300°.s±1 to determine each leg's peak torque as assessed by isokinetic dynamometer testing (Biodex System 4 Pro).
Measured: Week 0, Week 6, Week 10
Changes in aerobic fitness, as assessed using the Standardized Exponential Exercise Protocol (STEEP)
After a brief warm-up, participants will pedal on an ergometer 75-85 revolutions per minute (RPMs) at low resistance of approximately 2 metabolic equivalent of task (METs). The resistance will increase by 15% per minute until respiratory exchange ratio (RER) exceeds 1.0, maximum oxygen consumption (V02 max) is reached, or participant can no longer maintain pedaling speed.
Measured: Week 0, Week 6, Week 10
Changes in anaerobic power, as during a Wingate anaerobic power exercise test
Following a brief warm-up, participants will be instructed to pedal on an ergometer as hard and as fast as they can for 30 seconds at a resistance of 1 watt·kilogram-1, followed by a cool-down period. Changes in anaerobic power, will be as assessed by as changes in power outputs in watts (rpm·braking force).
Measured: Week 0, Week 6, Week 10
Changes in fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat mass.
Measured: Week 0, Week 6, Week 10
Changes in fat-free lean mass as assessed by DXA scans
Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat-free lean mass.
Measured: Week 0, Week 6, Week 10
Changes in tolerance for physical pain and discomfort
Changes in preference for tolerance for physical pain and discomfort will be assessed by self-report questionnaire responses to the Discomfort Intolerance Scale (DIS). This scale measures individual differences in ability to tolerate uncomfortable sensations. There are 7 items total. Although there are two subscales (measure ability to tolerate discomfort / pain and avoidance of physical discomfort) only total scores will be used. There are 7 items total. Items are scored 0 - 6 (total range 0 - 42), with higher scores indicating greater ability to tolerate physical discomfort. Average score on the total scale will be used.
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 Support and Exercise Survey. This questionnaire measures 13 items are scored on a scale of 1 - 5, with higher scores indicating greater perceived support. Total scores will be used, with ranges from 13 - 65. Higher scores indicate greater perceived support. Average score for the total scale will be used. Items may be answered twice, once for family members and once for friends.
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. This scale measures how much the psychological needs of autonomy, relatedness, and competence are satisfied during exercise. There are three subscales: autonomy, relatedness, and competence. Each subscale has 6 items rated on a 6-point scale. Higher scores indicate greater amounts of the construct. Total subscale scores may range from 6 to 36. Subscale averages will be used in analyses.
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).This scale measures how much exercise behavior is driven by intrinsic motivation, external motivation, interrogated motivation, identified motivation, introjected motivation, and amotivation (lack of motivation). There are 6 subscales with 4 items each: intrinsic, external, interrogated, identified, introjected, and amotivation. Items are measured on a 5-point scale, where higher scores indicated greater amounts of the construct. Subscale scores may range from 4 to 20. Average subscale scores will be used in analyses.
Measured: Week 0, Week 6, Week 10
Changes in how enjoyable physical activity is perceived to be
Changes in how enjoyable physical activity is perceived to be will be assessed by self-report questionnaire responses to the Physical Activity Enjoyment scale (PACES). This scale measures how enjoyable or unenjoyable physical activity is perceived to be. The measure consists of 18 questions and no subscales. Each question is measured on a 7-point scale, where higher scores indicate greater enjoyment. Total scores may range from 18 to 126. Average score will be used.
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 Borg Rating of Perceived Exertion Scale. This scale measures perceived physical exertion during exercise. There is only 1 item and no subscales. Scores may range from 0 to 10, with higher scores indicating greater perceived exertion. The total score will be used in analyses.
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 Numeric Ratings Pain Scale. This single item scale measures muscle pain/discomfort associated with physical activity. There are no subscales. Scores may range from 0 to 11, with higher scores indicating greater pain/discomfort. The total score will be used in analyses.
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 Barriers Self-Efficacy Scale (BARSE). This scale measures perceived ability to continue meeting exercise guidelines over the next 1 to 8 weeks. There are no subscales. 8 items are measured on an 11-point scale where higher scores indicate greater certainty in ability to complete exercise. Average score will be used in analyses.
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. This scale measures perceived confidence in ability to make time for exercise and persist in an exercise routine. There are 2 subscales: sticking to it (8 items) and making time for exercise (4 items). Items are measured on a 5-point scale where higher scores indicate greater confidence. Total scores may range from 8-40 (sticking to it) or 4-20 (making time). Average subscale scores will be used in analyses.
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 posted22 May 2017
- Study start29 Nov 2017
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 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
- NCT03162978
- Sponsor's protocol ID
- GFHNRC407
- Status last verified
- Apr 2025
- First submitted
- 19 May 2017
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Effect of Outcome Expectations on Psychological and Physiological Responses to Interval Exercise Training
- ClinicalTrials.gov ID
- NCT03162978
- Acronym / sponsor ID
- GFHNRC407
- Conditions
- Overweight, Obesity
- Keywords
- Exercise, behavior economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 22 May 2017 (actual)
- 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 research the effects of exercising at high intensities for short periods of time on exercise tolerance and motivation.
Detailed description
The proposed research will investigate whether adding a treatment component that focuses on positive outcome expectations of a high-intensity interval training (HIIT) intervention produces greater improvements in psychological and physiological study outcomes. This project will yield empirical evidence that will inform how to help Americans meet physical activity guidelines; how to develop exercise programs that are more likely to promote exercise as a habit; and maintenance of health and a healthy body weight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT + POE | Experimental | Other: HIIT + POEHigh-intensity interval training (HIIT) plus positive outcome expectations (POE) from participating in the exercise program. |
| HIIT only | Experimental | Other: HIIT onlyHigh-intensity interval training (HIIT) only. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index of 25-35 kg/m2
- Sedentary (not regularly engaging in exercise more than once per week)
- Weight stable (have not lost or gained over 10 pounds of body weight in the past 3 months)
Key exclusion criteria (7 listed)
- Taking any medications that affect energy expenditure or treat high blood pressure
- Tobacco use
- Pregnant or breastfeeding or plan to become pregnant in the next 3 months
- Have any medical conditions that prevent subject from safely exercising (e.g., orthopedic injuries, cardiovascular, liver, endocrine, or pulmonary diseases)
- Resting systolic blood pressure ≥ 140 mmHg
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 |
|---|---|---|
| HIIT + POESubjects will participate in high-intensity interval training (HIIT) with an additional treatment component to increase positive outcome expectations (POE) of exercise. | Other | HIIT + POE |
| HIIT onlySubjects will participate in high-intensity interval training (HIIT) only. | Other | HIIT only |
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). The PRETIE-Q measures preference for high intensity vs. low intensity exercise and ability to persist or tolerate the discomfort associationed with intense exercise. The PRETIE-Q consists of two subscales: Preference for Exercise Intensity and Tolerance of Exercise Intensity. Each subscale has 8 items rated on a 5 point response scale (range 8 - 40). Higher scores indicate greater preference for intense exercise and/or greater tolerance for exercise discomfort. Total scale scores are not used. Scale averages will be used.
15 secondary outcomes
Change in minutes of physical activity, as assessed by activity tracker
Time frame: Week 0, Week 6, Week 10
Changes in quadriceps and hamstring (thigh muscle) strength assessed separately on each leg
Time frame: Week 0, Week 6, Week 10
Changes in aerobic fitness, as assessed using the Standardized Exponential Exercise Protocol (STEEP)
Time frame: Week 0, Week 6, Week 10
Changes in anaerobic power, as during a Wingate anaerobic power exercise test
Time frame: Week 0, Week 6, Week 10
Changes in fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Time frame: Week 0, Week 6, Week 10
Changes in fat-free lean mass as assessed by DXA scans
Time frame: Week 0, Week 6, Week 10
Changes in tolerance for physical pain and discomfort
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 how enjoyable physical activity is perceived to be
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
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.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- 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 HIIT + POE and HIIT only 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 7 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.