Sprint to Fitness: Effect of Outcome Expectations on Responses to Interval Exercise Training
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIIT + POE
HIIT only
Sponsored by

About this trial
This is an interventional other trial for Overweight focused on measuring Exercise, behavior economics
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- USDA Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HIIT + POE
HIIT only
Arm Description
High-intensity interval training (HIIT) plus positive outcome expectations (POE) from participating in the exercise program.
High-intensity interval training (HIIT) only.
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). 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.
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 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).
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03162978
First Posted
May 19, 2017
Last Updated
January 23, 2022
Sponsor
USDA Grand Forks Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03162978
Brief Title
Sprint to Fitness: Effect of Outcome Expectations on Responses to Interval Exercise Training
Official Title
Effect of Outcome Expectations on Psychological and Physiological Responses to Interval Exercise Training
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Exercise, behavior economics
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIIT + POE
Arm Type
Experimental
Arm Description
High-intensity interval training (HIIT) plus positive outcome expectations (POE) from participating in the exercise program.
Arm Title
HIIT only
Arm Type
Experimental
Arm Description
High-intensity interval training (HIIT) only.
Intervention Type
Other
Intervention Name(s)
HIIT + POE
Intervention Description
Subjects will participate in high-intensity interval training (HIIT) with an additional treatment component to increase positive outcome expectations (POE) of exercise.
Intervention Type
Other
Intervention Name(s)
HIIT only
Intervention Description
Subjects will participate in high-intensity interval training (HIIT) only.
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). 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.
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 quadriceps and hamstring (thigh muscle) strength assessed separately on each leg
Description
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).
Time Frame
Week 0, Week 6, Week 10
Title
Changes in aerobic fitness, as assessed using the Standardized Exponential Exercise Protocol (STEEP)
Description
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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in anaerobic power, as during a Wingate anaerobic power exercise test
Description
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).
Time Frame
Week 0, Week 6, Week 10
Title
Changes in fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Description
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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in fat-free lean mass as assessed by DXA scans
Description
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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in tolerance for physical pain and discomfort
Description
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.
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 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.
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. 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.
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).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.
Time Frame
Week 0, Week 6, Week 10
Title
Changes in how enjoyable physical activity is perceived to be
Description
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.
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 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.
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 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.
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 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.
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. 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.
Time Frame
Week 0, Week 6, Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
Grand Forks Human Nutrition Research Center Current Nutrition Studies
Learn more about this trial
Sprint to Fitness: Effect of Outcome Expectations on Responses to Interval Exercise Training
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