Physical ActivityNCT03047590

Comparison of Affect-based, Self-selected, and Traditional Exercise Prescriptions

A study testing Choice-based Exercise Intensity, Positive Affect Focus and Heart rate-based Exercise Intensity in people with Physical Activity, run by Duke University 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

This study will evaluate adherence to four types of walking programs. Participants will be randomized to walking programs that included either (1) affect-based exercise intensity, (2) self-selected (or "choice-based") exercise intensity, (3) heart-rate based exercise intensity, or (4) heart-rate guided exercise… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Physical Activity
What is being tested?: Choice-based Exercise Intensity, Positive Affect Focus and Heart rate-based Exercise Intensity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 1 siteUnited States
Study dates: 21 Feb 2017to 29 Mar 2018
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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"

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University IBRC Lab
Durham, North Carolina, 27701

Other trials in United States

About this study

Read the 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.

Conditions: Physical Activity
Being tested: Choice-based Exercise Intensity, Positive Affect Focus, Heart rate-based Exercise Intensity
Keywords: exercise behavior, exercise prescription, affect-based exercise, affect-guided exercise, self-paced exercise, self-selected exercise
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Choice-based Exercise IntensityBehavioural
Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.
Positive Affect FocusBehavioural
Participants are instructed to focus on feeling good while exercising.
Heart rate-based Exercise IntensityBehavioural
Participants are instructed to regulate their exercise intensity based on their heart rate.

Study groups in NCT03047590
Study group	Role	What they receive
Choice-No Affect	Experimental	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. Receives: Behavioral: Choice-based Exercise Intensity
Choice-Affect	Experimental	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. Receives: Behavioral: Choice-based Exercise Intensity; Behavioral: Positive Affect Focus
No Choice-Affect	Experimental	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. Receives: Behavioral: Positive Affect Focus; Behavioral: Heart rate-based Exercise Intensity
No Choice-No Affect	Active comparator	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. Receives: Behavioral: Heart rate-based Exercise Intensity

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in objectively measured exercise behavior
Minutes per week of objectively measured exercise behavior.
Measured: This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)

Secondary outcomes (6)

Change in self-reported exercise behavior
Minutes per week of self-reported exercise behavior that is reported using exercise log.
Measured: This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
Change in affective attitudes
Affective attitudes toward exercise
Measured: Measured during baseline assessment period and at the end of the intervention
Self-reported intrinsic motivation (questionnaires)
Intrinsic motivation for exercise program
Measured: Two weeks into study intervention
Enjoyment
Enjoyment of exercise program.
Measured: Measured at the end of the intervention period (4 weeks)
Change in weight
Body weight
Measured: Measured at the beginning and end of the study (6 weeks).
Change in resting heart rate
Resting heart rate
Measured: Measured at the beginning and end of the study (6 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 201729 Mar 2018

First posted9 Feb 2017 (estimated)
Study start21 Feb 2017
Primary completion29 Mar 2018
Study completion29 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03047590
Sponsor's protocol ID: D0991
Status last verified: Jul 2018
First submitted: 2 Feb 2017
Last updated: 9 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The investigators retain ownership of all study data, but are willing to share anonymized data for transparency purposes at the conclusion of the study. Data may be requested by contacting the Principal Investigator.

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.
PubMed 27310568
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.
PubMed 25223963

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Affect-based, Self-selected, and Traditional Exercise Prescriptions
ClinicalTrials.gov ID: NCT03047590
Acronym / sponsor ID: D0991
Conditions: Physical Activity
Keywords: exercise behavior, exercise prescription, affect-based exercise, affect-guided exercise, self-paced exercise, self-selected exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 21 Feb 2017 (actual)
Primary completion: 29 Mar 2018 (actual)
Study completion: 29 Mar 2018 (actual)
First posted: 9 Feb 2017 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Choice-No Affect	Experimental	Behavioral: Choice-based Exercise IntensityThese 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.
Choice-Affect	Experimental	Behavioral: Choice-based Exercise Intensity, Behavioral: Positive Affect FocusThese 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.
No Choice-Affect	Experimental	Behavioral: Positive Affect Focus, Behavioral: Heart rate-based Exercise IntensityThese 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.
No Choice-No Affect	Active comparator	Behavioral: Heart rate-based Exercise IntensityThese 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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+)

Key exclusion criteria (1 listed)

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

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
Choice-based Exercise IntensityParticipants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.	Behavioural	Choice-Affect, Choice-No Affect
Positive Affect FocusParticipants are instructed to focus on feeling good while exercising.	Behavioural	Choice-Affect, No Choice-Affect
Heart rate-based Exercise IntensityParticipants are instructed to regulate their exercise intensity based on their heart rate.	Behavioural	No Choice-Affect, No Choice-No Affect

Primary outcome

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.

6 secondary outcomes

Change in self-reported exercise behavior
Time frame: 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
Self-reported intrinsic motivation (questionnaires)
Time frame: Two weeks into study intervention
Enjoyment
Time frame: 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).
Change in resting heart rate
Time frame: Measured at the beginning and end of the study (6 weeks).

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 9 Jul 2018.
Background: PubMed 27310568Baldwin 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.
Background: PubMed 25223963Williams 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.
Individual participant dataSharing planned: Yes. The investigators retain ownership of all study data, but are willing to share anonymized data for transparency purposes at the conclusion of the study. Data may be requested by contacting the Principal Investigator.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Choice-based Exercise Intensity, Positive Affect Focus and Heart rate-based Exercise Intensity in people with Physical Activity, run by Duke University 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 6 inclusion and 1 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 9 Jul 2018. 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 objectively measured exercise behavior (time frame: This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03047590, which also lists 2 linked publications.

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 9 Jul 2018.