Feelings About Exercise

• ClinicalTrials.gov Identifier: NCT03598647
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Results First Posted: September 28, 2021
• Last Update Posted: September 28, 2021
• Sponsor: The Miriam Hospital
• Collaborators: Brown University; National Institute of General Medical Sciences (NIGMS): U54GM115677
• Information provided by (Responsible Party): The Miriam Hospital

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: July 31, 2018
• Actual Primary Completion Date: July 12, 2019
• Actual Study Completion Date: October 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) [ 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
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Secondary Outcome Measures :

1. 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
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

United States, Rhode Island

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)

Documents provided by The Miriam Hospital:

Study Protocol  [PDF] January 23, 2019

Statistical Analysis Plan  [PDF] August 3, 2021

Informed Consent Form  [PDF] November 20, 2017

More Information

• Responsible Party: The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT03598647
• Other Study ID Numbers: 1179772
• First Posted: July 26, 2018
• Results First Posted: September 28, 2021
• Last Update Posted: September 28, 2021
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• 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; Overnutrition; Nutrition Disorders; Overweight; Body Weight