- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03047590
Comparison of Affect-based, Self-selected, and Traditional Exercise Prescriptions
Study Overview
Status
Conditions
Detailed Description
The purpose of this study is to determine if an "affect-based" or "choice-based" exercise prescription is more effective for behavior change than a traditional, "moderate-intensity" exercise prescription. Prior research suggests that "choice-based" or "self-selected" exercise intensity is more pleasant and adhered to than "moderate-intensity exercise" (Williams et al., 2014). Similarly, affect-based exercise prescriptions (i.e., an exercise prescription where intensity is regulated based on the pleasure-displeasure one feels while exercising) appear to have merit (Baldwin, Kangas, Denman, Smits, Yamada, & Otto, 2016).
However, choice-based and affect-based exercise prescriptions have not been compared to each other. Further, it is unknown if it is the intensity regulation that matters (e.g., "choose an intensity that feels good" or the focus on affect (e.g., "focus on feeling good). Third, prior research has not objectively measured physical activity behavior.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27701
- Duke University IBRC Lab
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be fluent in English
- Must be able to walk
- Exercise less than 90 minutes per week at a moderate-intensity
- Must be able to attend laboratory visits
- Must have mobile internet accent and a personal smartphone (iPhone iOS 9+ or Android OS 4.3+)
- Can safely exercise at an intensity that is at least "moderate"
Exclusion Criteria:
- People who are recommended to have medical clearance prior to exercising, according to the American College of Sports Medicine's preparticipation screening criteria, will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Choice-No Affect
These participants self-select (i.e., choose) their exercise intensity with the goal of walking 30-60 minutes on most days of the week.
For safety reasons, they are instructed not to exceed 59% of their heart rate reserve.
This is choice-based exercise intensity with no focus on positive affect.
|
Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.
|
|
Experimental: Choice-Affect
These participants self-select their exercise intensity with the goal of walking 30-60 minutes on most days of the week.
They're instructed to choose the intensity that makes them feel the best.
For safety reasons, they are instructed not to exceed 59% of their heart rate reserve.
This is choice-based exercise intensity with a focus on positive affect.
|
Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.
Participants are instructed to focus on feeling good while exercising.
|
|
Experimental: No Choice-Affect
These participants regulate their exercise intensity using their heart rate, with the goal of walking 30-60 minutes on most days of the week.
The intensity is "moderate" according to the American College of Sports Medicine (40-59% of their heart rate reserve).
Meanwhile, these participants are instructed to focus on the "good feelings" that come with exercise.
this is heart rate-based exercise intensity with a focus on positive affect.
|
Participants are instructed to focus on feeling good while exercising.
Participants are instructed to regulate their exercise intensity based on their heart rate.
|
|
Active Comparator: No Choice-No Affect
These participants regulate their exercise intensity using their heart rate, with the goal of walking 30-60 minutes on most days of the week.
The intensity is "moderate" according to the American College of Sports Medicine (40-59% of their heart rate reserve).
This is heart rate-based exercise intensity with no focus on positive affect.
|
Participants are instructed to regulate their exercise intensity based on their heart rate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in objectively measured exercise behavior
Time Frame: This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
|
Minutes per week of objectively measured exercise behavior.
|
This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-reported exercise behavior
Time Frame: This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
|
Minutes per week of self-reported exercise behavior that is reported using exercise log.
|
This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
|
|
Change in affective attitudes
Time Frame: Measured during baseline assessment period and at the end of the intervention
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Affective attitudes toward exercise
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Measured during baseline assessment period and at the end of the intervention
|
|
Self-reported intrinsic motivation (questionnaires)
Time Frame: Two weeks into study intervention
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Intrinsic motivation for exercise program
|
Two weeks into study intervention
|
|
Enjoyment
Time Frame: Measured at the end of the intervention period (4 weeks)
|
Enjoyment of exercise program.
|
Measured at the end of the intervention period (4 weeks)
|
|
Change in weight
Time Frame: Measured at the beginning and end of the study (6 weeks).
|
Body weight
|
Measured at the beginning and end of the study (6 weeks).
|
|
Change in resting heart rate
Time Frame: Measured at the beginning and end of the study (6 weeks).
|
Resting heart rate
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Measured at the beginning and end of the study (6 weeks).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Baldwin AS, Kangas JL, Denman DC, Smits JA, Yamada T, Otto MW. Cardiorespiratory fitness moderates the effect of an affect-guided physical activity prescription: a pilot randomized controlled trial. Cogn Behav Ther. 2016 Nov;45(6):445-57. doi: 10.1080/16506073.2016.1194454. Epub 2016 Jun 16.
- Williams DM, Dunsiger S, Miranda R Jr, Gwaltney CJ, Emerson JA, Monti PM, Parisi AF. Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Ann Behav Med. 2015 Apr;49(2):280-5. doi: 10.1007/s12160-014-9642-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D0991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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