- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03598647
Feelings About Exercise
August 31, 2021 updated by: The Miriam Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02903
- Miriam Hospital's Weight Control and Diabetes Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Physical activity information - for non-exercisers only
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.
|
Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.
|
Experimental: Affect and physical activity - for non-exercisers only
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.
|
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.
|
No Intervention: Exercisers
Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
|
|
No Intervention: Non-exercisers
Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Prior to exercise
|
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.
|
average score assessed every 5 minutes during exercise, up to 30 minutes
|
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.
|
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
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.
|
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
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.
|
15 minutes and 7 days post-exercise
|
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.
|
prior to exercise session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-exercise Affect (Session 3)
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
|
Prior to exercise
|
Mean During Exercise Affect (Session 3)
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.
|
average score assessed every 5 minutes during exercise, up to 30 minutes
|
Post-exercise Affect (Session 3)
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.
|
15 minutes post-exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Williams, PhD, Brown University
- Principal Investigator: Jessica Unick, PhD, The Miriam Hospital
- Principal Investigator: Kathryn Demos, PhD, The Miriam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2018
Primary Completion (Actual)
July 12, 2019
Study Completion (Actual)
October 22, 2019
Study Registration Dates
First Submitted
July 16, 2018
First Submitted That Met QC Criteria
July 16, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
August 31, 2021
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1179772
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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