Physical ActivityNCT03598647
Feelings About Exercise
A study testing Affect and physical activity and Physical activity information in people with Physical Activity and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study seeks to investigate why some individuals exercise more than others by focusing on feelings related to exercise. This two part study first examines whether regular exercisers (n=30) and non-exercisers (n=30) differ in how a 30-minute moderate-intensity exercise bout makes them feel. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Obesity
- What is being tested?
- Affect and physical activity and Physical activity information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 22 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- BMI between 25.0 and <40.0 kg/m2
- Either a 'Non-exerciser', defined as reporting exercising at a moderate-intensity for <30 min/week over the past 6 months and a most recent typical week or an 'exerciser', defined as exercising for ≥150 min/week over the past 6 months and a most recent typical week.
Who cannot join
- Presence of any condition that would limit one's ability to exercise (e.g., orthopedic limitations)
- History of coronary artery disease (i.e., myocardial infarction or symptoms of angina), stroke, diabetes, or pulmonary disease (e.g., COPD or emphysema).
- Currently taking any medication that would alter heart rate (e.g., beta blocker)
- Women who are pregnant or nursing
- Uncontrolled hypertension (resting blood pressure ≥140/90 mmHg)
- Exercising >30 min/week but <150 min/week (i.e., neither 'non-exerciser' nor 'exerciser')
- Use of medications for weight loss, or current participation in another weight loss program
- Bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Affective Responses to Physical Activity: A Novel Intervention Target for Increasing Physical Activity
This study seeks to investigate why some individuals exercise more than others by focusing on feelings related to exercise. This two part study first examines whether regular exercisers (n=30) and non-exercisers (n=30) differ in how a 30-minute moderate-intensity exercise bout makes them feel. All participants will walk on a treadmill for 30 minutes on two separate occasions and will be asked to report on how they feel before, during, and after exercise, how they anticipate that exercise will make them feel, and how they remembered feeling during exercise. In addition, after exercise session #2, non-exercisers will be randomized to: 1) a brief intervention focused on providing general information about the physical activity guidelines, or 2) a brief intervention which provides general information about physical activity guidelines, but also focuses on affective responses to physical activity. Non-exercisers will complete an identical, third exercise session approximately 1-week following this intervention. Further, all participants will receive a 12-week, Internet-delivered weight loss program following all exercise visits and physical activity will be assessed before and after the weight loss program.
- Conditions
- Physical Activity, Obesity
- Being tested
- Affect and physical activity, Physical activity information
- Keywords
- exercise, physical activity, obesity, weight loss
- Medical subject headings
- Motor Activity, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect and physical activityBehavioural
The focus of this intervention is to help the participant to become more aware of their positive feelings and experiences related to exercise. They will learn about typical affective responses to exercise, view their own affective responses to exercise, and they will be taught cognitive strategies for altering affective responses to exercise. Participants will also receive general information about exercise safety, physical activity guidelines, and exercise intensity.
Physical activity informationBehavioural
Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity information - for non-exercisers only | Active comparator | Non-exercisers randomized to this condition will receive basic information about physical activity. This includes the national physical activity guidelines,clarification of 'moderate-intensity', exercise safety, and the progression of physical activity within the weight loss program. Receives: Behavioral: Physical activity information |
| Affect and physical activity - for non-exercisers only | Experimental | Non-exercisers randomized to this condition will receive the same basic information about physical activity as described above, but they will also receive a brief intervention focused on affective responses to exercise. Receives: Behavioral: Affect and physical activity |
| Exercisers | No intervention | Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
| Non-exercisers | No intervention | Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-exercise Affect (Session 1)
Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect
Measured: Prior to exercise
Mean During Exercise Affect (Session 1)
Average during exercise Feeling Scale (FS) score which was assessed every 5 minutes during exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
Measured: average score assessed every 5 minutes during exercise, up to 30 minutes
Post-exercise Affect (Session 1)
Feeling Scale (FS) score 15 minutes post-exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
Measured: 15 minutes post-exercise
Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect
Calculated as follows: recalled during exercise affect (assessed 7 days post-exercise) minus actual during exercise affect (average of Feeling Scale scores every 5 minutes during exercise). Possible scores for both recalled affect and actual affect range from -5 to +5, where higher numbers indicate more positive affect. A negative change value indicates that participants remembered feeling less positive during exercise than they actually felt.
Measured: average score assessed every 5 minutes during exercise, up to 30 minutes, and 7 days post-exercise
Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect
Calculated as follows: recalled post-exercise affect (assessed 7 days following exercise session) minus actual post-exercise affect (Feeling Scale score assessed 15 minutes post-exercise). Possible scores for both recalled affect and actual affect range from -5 to +5, where higher numbers indicate more positive affect. A negative change value indicates that participants remembered feeling less positive post-exercise than they actually felt.
Measured: 15 minutes and 7 days post-exercise
Anticipated During Exercise Affect (Session 2)
How one anticipates that they will feel during exercise session 2 (an exercise session that is identical to exercise session 1).This was assessed prior to exercise session 2 via a 100 mm visual analogue scale (range 1-100) where a higher number indicates more positive affect.
Measured: prior to exercise session
Secondary outcomes (3)
Pre-exercise Affect (Session 3)
Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect
Measured: Prior to exercise
Mean During Exercise Affect (Session 3)
Average during exercise Feeling Scale (FS) score which was assessed every 5 minutes during exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
Measured: average score assessed every 5 minutes during exercise, up to 30 minutes
Post-exercise Affect (Session 3)
Feeling Scale (FS) score 15 minutes post-exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
Measured: 15 minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start31 Jul 2018
- Primary completion12 Jul 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical ActivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Jessica Unick, PhD, Principal investigator, The Miriam HospitalKathryn Demos, PhD, Principal investigator, The Miriam HospitalDavid Williams, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598647
- Sponsor's protocol ID
- 1179772
- Status last verified
- Nov 2019
- First submitted
- 16 Jul 2018
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Responses to Physical Activity: A Novel Intervention Target for Increasing Physical Activity
- ClinicalTrials.gov ID
- NCT03598647
- Acronym / sponsor ID
- 1179772
- Conditions
- Physical Activity, Obesity
- Keywords
- exercise, physical activity, obesity, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University, National Institute of General Medical Sciences (NIGMS)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 28 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to investigate why some individuals exercise more than others by focusing on feelings related to exercise. This two part study first examines whether regular exercisers (n=30) and non-exercisers (n=30) differ in how a 30-minute moderate-intensity exercise bout makes them feel. All participants will walk on a treadmill for 30 minutes on two separate occasions and will be asked to report on how they feel before, during, and after exercise, how they anticipate that exercise will make them feel, and how they remembered feeling during exercise. In addition, after exercise session #2, non-exercisers will be randomized to: 1) a brief intervention focused on providing general information about the physical activity guidelines, or 2) a brief intervention which provides general information about physical activity guidelines, but also focuses on affective responses to physical activity. Non-exercisers will complete an identical, third exercise session approximately 1-week following this intervention. Further, all participants will receive a 12-week, Internet-delivered weight loss program following all exercise visits and physical activity will be assessed before and after the weight loss program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical activity information - for non-exercisers only | Active comparator | Behavioral: Physical activity informationNon-exercisers randomized to this condition will receive basic information about physical activity. This includes the national physical activity guidelines,clarification of 'moderate-intensity', exercise safety, and the progression of physical activity within the weight loss program. |
| Affect and physical activity - for non-exercisers only | Experimental | Behavioral: Affect and physical activityNon-exercisers randomized to this condition will receive the same basic information about physical activity as described above, but they will also receive a brief intervention focused on affective responses to exercise. |
| Exercisers | No intervention | –Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
| Non-exercisers | No intervention | –Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- BMI between 25.0 and <40.0 kg/m2
- Either a 'Non-exerciser', defined as reporting exercising at a moderate-intensity for <30 min/week over the past 6 months and a most recent typical week or an 'exerciser', defined as exercising for ≥150 min/week over the past 6 months and a most recent typical week.
Key exclusion criteria (8 listed)
- Presence of any condition that would limit one's ability to exercise (e.g., orthopedic limitations)
- History of coronary artery disease (i.e., myocardial infarction or symptoms of angina), stroke, diabetes, or pulmonary disease (e.g., COPD or emphysema).
- Currently taking any medication that would alter heart rate (e.g., beta blocker)
- Women who are pregnant or nursing
- Uncontrolled hypertension (resting blood pressure ≥140/90 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 |
|---|---|---|
| Affect and physical activityThe focus of this intervention is to help the participant to become more aware of their positive feelings and experiences related to exercise. They will learn about typical affective responses to exercise, view their own affective responses to exercise, and they will be taught cognitive strategies for altering affective responses to exercise. Participants will also receive general information about exercise safety, physical activity guidelines, and exercise intensity. | Behavioural | Affect and physical activity - for non-exercisers only |
| Physical activity informationParticipants will receive general information about exercise safety, physical activity guidelines, and exercise intensity. | Behavioural | Physical activity information - for non-exercisers only |
Primary outcome
Pre-exercise Affect (Session 1)
Time frame: Prior to exercise
Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect
Mean During Exercise Affect (Session 1)
Time frame: average score assessed every 5 minutes during exercise, up to 30 minutes
Average during exercise Feeling Scale (FS) score which was assessed every 5 minutes during exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
Post-exercise Affect (Session 1)
Time frame: 15 minutes post-exercise
Feeling Scale (FS) score 15 minutes post-exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect
Time frame: average score assessed every 5 minutes during exercise, up to 30 minutes, and 7 days post-exercise
Calculated as follows: recalled during exercise affect (assessed 7 days post-exercise) minus actual during exercise affect (average of Feeling Scale scores every 5 minutes during exercise). Possible scores for both recalled affect and actual affect range from -5 to +5, where higher numbers indicate more positive affect. A negative change value indicates that participants remembered feeling less positive during exercise than they actually felt.
Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect
Time frame: 15 minutes and 7 days post-exercise
Calculated as follows: recalled post-exercise affect (assessed 7 days following exercise session) minus actual post-exercise affect (Feeling Scale score assessed 15 minutes post-exercise). Possible scores for both recalled affect and actual affect range from -5 to +5, where higher numbers indicate more positive affect. A negative change value indicates that participants remembered feeling less positive post-exercise than they actually felt.
Anticipated During Exercise Affect (Session 2)
Time frame: prior to exercise session
How one anticipates that they will feel during exercise session 2 (an exercise session that is identical to exercise session 1).This was assessed prior to exercise session 2 via a 100 mm visual analogue scale (range 1-100) where a higher number indicates more positive affect.
3 secondary outcomes
Pre-exercise Affect (Session 3)
Time frame: Prior to exercise
Mean During Exercise Affect (Session 3)
Time frame: average score assessed every 5 minutes during exercise, up to 30 minutes
Post-exercise Affect (Session 3)
Time frame: 15 minutes post-exercise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
Jessica Unick, PhD principal investigator
The Miriam Hospital
Kathryn Demos, PhD principal investigator
The Miriam Hospital
David Williams, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affect and physical activity and Physical activity information in people with Physical Activity and Obesity, run by The Miriam Hospital 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 8 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 28 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre-exercise Affect (Session 1) (time frame: Prior to exercise). The study lists 6 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 28 Sep 2021.