Feelings About Exercise

NCT ID: NCT03598647

Last Updated: 2021-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-10-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Activity Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Physical activity information

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Affect and physical activity

Intervention Type 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.

Exercisers

Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-exercisers

Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Physical activity information

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brown University

OTHER

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jessica Unick, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Kathryn Demos, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

David Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1179772

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multiphase Activity Promotion Study
NCT02592590 COMPLETED NA
Web-based Physical Activity Program
NCT01218412 UNKNOWN PHASE1