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| Name | Class |
|---|---|
| Brown University | OTHER |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Affect and physical activity | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Prior to exercise |
| Mean During Exercise Affect (Session 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Unick, PhD | The Miriam Hospital | Principal Investigator |
| Kathryn Demos, PhD | The Miriam Hospital | Principal Investigator |
| David Williams, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miriam Hospital's Weight Control and Diabetes Research Center | Providence | Rhode Island | 02903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercisers | Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
| FG001 | Non-exercisers | Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
| FG002 | Physical Activity Information | After the completion of exercise sessions 1 and 2 (which were necessary for the aims comparing exercisers vs. non-exercisers), non-exercisers randomized to this condition received basic information about physical activity, including the national physical activity guidelines, clarification of 'moderate-intensity', exercise safety, and the progression of physical activity within the weight loss program. |
| FG003 | Affect and Physical Activity | After the completion of exercise sessions 1 and 2 (which were necessary for the aims comparing exercisers vs. non-exercisers), non-exercisers randomized to this condition received the same basic information about physical activity as the 'physical activity information' group but they also received a brief intervention focused on affective responses to exercise. The focus of this intervention was to help the participant to become more aware of their positive feelings and experiences related to exercise. They learned about typical affective responses to exercise, viewed their own affective responses to exercise, and were taught cognitive strategies for altering affective responses to exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Exercisers vs. Non-exercisers |
| |||||||||||||
| Interventions for Non-exercisers |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercisers | Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
| BG001 | Non-exercisers | Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Prior to exercise |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercisers | Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Unick, PD (Principal Investigator) | The Miriam Hospital | 401-793-8966 | junick@lifespan.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2019 | Aug 31, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2021 | Aug 3, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2017 | Feb 7, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Physical activity information | Behavioral | Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity. |
|
| 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. | prior to exercise session |
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) | 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 |
| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Self-reported exercise minutes (min/week) over past 6 months | Mean | Standard Deviation | min/week |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | average score assessed every 5 minutes during exercise, up to 30 minutes |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes post-exercise |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | average score assessed every 5 minutes during exercise, up to 30 minutes, and 7 days post-exercise |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes and 7 days post-exercise |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | prior to exercise session |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Prior to exercise |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | average score assessed every 5 minutes during exercise, up to 30 minutes |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes post-exercise |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Non-exercisers | Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Physical Activity Information | 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. Physical activity information: Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Affect and Physical Activity | 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. Affect and physical activity: 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |