Feelings About Exercise

NCT03598647 | Completed Results

• 1 other identifier: 1179772
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Obesity

Keywords

exercise; physical activity; obesity; weight loss

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Secondary Outcomes (3)

• Pre-exercise Affect (Session 3)

  Prior to exercise

• Mean During Exercise Affect (Session 3)

  average score assessed every 5 minutes during exercise, up to 30 minutes

• Post-exercise Affect (Session 3)

  15 minutes post-exercise

Study Arms (4)

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.

Behavioral: Physical activity information

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.

Behavioral: Affect and physical activity

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

Interventions

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.

Affect and physical activity - for non-exercisers only

Physical activity information BEHAVIORAL

Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.

Physical activity information - for non-exercisers only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Motor Activity; Obesity; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jessica Unick, PD (Principal Investigator)
• Organization: The Miriam Hospital

junick@lifespan.org

401-793-8966

Study Officials

• Jessica Unick, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

• Kathryn Demos, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

• David Williams, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 31, 2018
• Primary Completion: July 12, 2019
• Study Completion: October 22, 2019
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)