Clinical trial NCT03598647: Feelings About Exercise
Official title: Affective Responses to Physical Activity: A Novel Intervention Target for Increasing Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Obesity
Keywords: exercise
physical activity
obesity
weight loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pre-exercise Affect (Session 1)
timeFrame: Prior to exercise
measure: Mean During Exercise Affect (Session 1)
timeFrame: average score assessed every 5 minutes during exercise, up to 30 minutes
measure: Post-exercise Affect (Session 1)
timeFrame: 15 minutes post-exercise
measure: Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect
timeFrame: average score assessed every 5 minutes during exercise, up to 30 minutes, and 7 days post-exercise
measure: Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect
timeFrame: 15 minutes and 7 days post-exercise
measure: Anticipated During Exercise Affect (Session 2)
timeFrame: prior to exercise session
Secondary outcomes:
measure: Pre-exercise Affect (Session 3)
timeFrame: Prior to exercise
measure: Mean During Exercise Affect (Session 3)
timeFrame: average score assessed every 5 minutes during exercise, up to 30 minutes
measure: Post-exercise Affect (Session 3)
timeFrame: 15 minutes post-exercise
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Jessica Unick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Kathryn Demos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: David Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: