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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT03162978
Study groupRoleWhat they receive
HIIT + POEExperimentalHigh-intensity interval training (HIIT) plus positive outcome expectations (POE) from participating in the exercise program.
Receives: Other: HIIT + POE
HIIT onlyExperimentalHigh-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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted22 May 2017
  2. Study start29 Nov 2017
  3. Primary completion21 Oct 2019
  4. Study completion21 Oct 2019

Resources

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)
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

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.

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