Feelings About Exercise

• Sponsor: The Miriam Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03598647
• Collaborator: Brown University (Other), National Institute of General Medical Sciences (NIGMS): U54GM115677 (Other)
• Enrollment: 60
• Location: 1
• Arms: 4
• Actual Duration (Months): 14.7
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity; Obesity	Behavioral: Affect and physical activity; Behavioral: Physical activity information	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Affective Responses to Physical Activity: A Novel Intervention Target for Increasing Physical Activity
• Actual Study Start Date: Jul 31, 2018
• Actual Primary Completion Date: Jul 12, 2019
• Actual Study Completion Date: Oct 22, 2019

Arms and Interventions

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.	Behavioral: Physical activity information; 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.	Behavioral: 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.
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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Secondary Outcome Measures

1. 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

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miriam Hospital's Weight Control and Diabetes Research Center	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• The Miriam Hospital
• Brown University
• National Institute of General Medical Sciences (NIGMS): U54GM115677

Investigators

• Principal Investigator: Jessica Unick, PhD, The Miriam Hospital
• Principal Investigator: Kathryn Demos, PhD, The Miriam Hospital
• Principal Investigator: David Williams, PhD, Brown University

Study Documents (Full-Text)

• Study Protocol - Jan 23, 2019
• Statistical Analysis Plan - Aug 3, 2021
• Informed Consent Form - Nov 20, 2017

More Information

Publications

None provided.

• Responsible Party: The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT03598647
• Other Study ID Numbers: 1179772
• First Posted: Jul 26, 2018
• Last Update Posted: Sep 28, 2021
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Miriam Hospital: exercise; physical activity; obesity; weight loss
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Exercisers	Non-exercisers	Physical Activity Information	Affect and Physical Activity
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	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.	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.
Period Title: Exercisers vs. Non-exercisers
STARTED	30	30	0	0
COMPLETED	29	30	0	0
NOT COMPLETED	1	0	0	0
Period Title: Exercisers vs. Non-exercisers
STARTED	0	0	14	16
COMPLETED	0	0	14	16
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Exercisers	Non-exercisers	Total
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Total of all reporting groups
Overall Participants	29	30	59
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.2 (8.9)	45.0 (11.3)	47.1 (10.3)
Sex: Female, Male (Count of Participants)
Female	22 75.9%	25 83.3%	47 79.7%
Male	7 24.1%	5 16.7%	12 20.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.4%	2 6.7%	3 5.1%
Not Hispanic or Latino	28 96.6%	28 93.3%	56 94.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	29 100%	30 100%	59 100%
Self-reported exercise minutes (min/week) over past 6 months (min/week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [min/week]	285.9 (148.8)	14.0 (15.2)	147.6 (172.0)

Outcome Measures

1. Primary Outcome

Title	Pre-exercise Affect (Session 1)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercisers	Non-exercisers
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	3.97 (1.40)	2.70 (2.15)

2. Primary Outcome

Title	Mean During Exercise Affect (Session 1)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercisers	Non-exercisers
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	3.53 (1.64)	2.71 (1.54)

3. Primary Outcome

Title	Post-exercise Affect (Session 1)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercisers	Non-exercisers
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	4.03 (1.32)	3.80 (1.27)

4. Primary Outcome

Title	Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercisers	Non-exercisers
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	-.77 (1.22)	-.80 (1.23)

5. Primary Outcome

Title	Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercisers	Non-exercisers
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	-1.07 (1.21)	-0.76 (1.81)

6. Primary Outcome

Title	Anticipated During Exercise Affect (Session 2)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercisers	Non-exercisers
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Measure Participants	29	30
Mean (Standard Deviation) [units on a scale]	71.3 (18.7)	54.1 (21.3)

7. Secondary Outcome

Title	Pre-exercise Affect (Session 3)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Information	Affect and Physical Activity
Arm/Group Description	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.	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.
Measure Participants	14	16
Mean (Standard Deviation) [units on a scale]	2.11 (1.70)	2.94 (1.53)

8. Secondary Outcome

Title	Mean During Exercise Affect (Session 3)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Information	Affect and Physical Activity
Arm/Group Description	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.	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.
Measure Participants	14	16
Mean (Standard Deviation) [units on a scale]	3.14 (1.69)	3.14 (1.24)

9. Secondary Outcome

Title	Post-exercise Affect (Session 3)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity Information	Affect and Physical Activity
Arm/Group Description	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.	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.
Measure Participants	14	16
Mean (Standard Deviation) [units on a scale]	3.71 (1.27)	3.94 (0.85)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Exercisers		Non-exercisers		Physical Activity Information		Affect and Physical Activity
Arm/Group Description	Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week		Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week		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.		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.
All Cause Mortality
	Exercisers		Non-exercisers		Physical Activity Information		Affect and Physical Activity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)		0/14 (0%)		0/16 (0%)
Serious Adverse Events
	Exercisers		Non-exercisers		Physical Activity Information		Affect and Physical Activity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)		0/14 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Exercisers		Non-exercisers		Physical Activity Information		Affect and Physical Activity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)		0/14 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.