Physical Activity, Obesity
Conditions
Keywords
exercise, physical activity, obesity, weight loss
Brief 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. 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.
Interventions
BEHAVIORALAffect 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.
BEHAVIORALPhysical activity information
Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.
Sponsors
Brown University
National Institute of General Medical Sciences (NIGMS)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anticipated During Exercise Affect (Session 2) | 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. |
| Post-exercise Affect (Session 1) | 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 | 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 | 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. |
| Pre-exercise Affect (Session 1) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean During Exercise Affect (Session 3) | 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 3) | 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. |
| Pre-exercise Affect (Session 3) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercisers Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week | 29 |
| Non-exercisers Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week | 30 |
| Total | 59 |
Baseline characteristics
| Characteristic | Exercisers | Non-exercisers | Total |
|---|---|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 8.9 | 45.0 years STANDARD_DEVIATION 11.3 | 47.1 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 28 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 29 Participants | 30 Participants | 59 Participants |
| Self-reported exercise minutes (min/week) over past 6 months | 285.9 min/week STANDARD_DEVIATION 148.8 | 14.0 min/week STANDARD_DEVIATION 15.2 | 147.6 min/week STANDARD_DEVIATION 172 |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 47 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 29 | 0 / 30 | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 | 0 / 14 | 0 / 16 |
Outcome results
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.
Time frame: prior to exercise session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Anticipated During Exercise Affect (Session 2) | 71.3 units on a scale | Standard Deviation 18.7 |
| Non-exercisers | Anticipated During Exercise Affect (Session 2) | 54.1 units on a scale | Standard Deviation 21.3 |
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.
Time frame: average score assessed every 5 minutes during exercise, up to 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Mean During Exercise Affect (Session 1) | 3.53 units on a scale | Standard Deviation 1.64 |
| Non-exercisers | Mean During Exercise Affect (Session 1) | 2.71 units on a scale | Standard Deviation 1.54 |
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.
Time frame: average score assessed every 5 minutes during exercise, up to 30 minutes, and 7 days post-exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect | -.77 units on a scale | Standard Deviation 1.22 |
| Non-exercisers | Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect | -.80 units on a scale | Standard Deviation 1.23 |
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.
Time frame: 15 minutes and 7 days post-exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect | -1.07 units on a scale | Standard Deviation 1.21 |
| Non-exercisers | Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect | -0.76 units on a scale | Standard Deviation 1.81 |
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.
Time frame: 15 minutes post-exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Post-exercise Affect (Session 1) | 4.03 units on a scale | Standard Deviation 1.32 |
| Non-exercisers | Post-exercise Affect (Session 1) | 3.80 units on a scale | Standard Deviation 1.27 |
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
Time frame: Prior to exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Pre-exercise Affect (Session 1) | 3.97 units on a scale | Standard Deviation 1.4 |
| Non-exercisers | Pre-exercise Affect (Session 1) | 2.70 units on a scale | Standard Deviation 2.15 |
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.
Time frame: average score assessed every 5 minutes during exercise, up to 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Mean During Exercise Affect (Session 3) | 3.14 units on a scale | Standard Deviation 1.69 |
| Non-exercisers | Mean During Exercise Affect (Session 3) | 3.14 units on a scale | Standard Deviation 1.24 |
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.
Time frame: 15 minutes post-exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Post-exercise Affect (Session 3) | 3.71 units on a scale | Standard Deviation 1.27 |
| Non-exercisers | Post-exercise Affect (Session 3) | 3.94 units on a scale | Standard Deviation 0.85 |
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
Time frame: Prior to exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercisers | Pre-exercise Affect (Session 3) | 2.11 units on a scale | Standard Deviation 1.7 |
| Non-exercisers | Pre-exercise Affect (Session 3) | 2.94 units on a scale | Standard Deviation 1.53 |