Physical Activity Clinical Trial
— EVOLVEOfficial title:
A Novel Behavioral Approach for the Adoption and Maintenance of Habitual Physical Activity
Verified date | June 2020 |
Source | The Miriam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to develop and test a brief program to help overweight people
become more physically active. We plan to design a program that teaches people how to become
more active by identifying how fitness enables them to live their lives better.
Participants will be asked to complete questionnaires and wear a device that tracks their
exercise for 1 week. If accepted into the study, they will receive a 1 day program designed
to help them exercise more. Then they will receive phone calls and emails for support after
the program. Finally, participants will come in 3 and 6 months after the program to complete
the same questionnaires and wear the exercise tracker again.
The study is primarily interested in increasing exercise levels, and so we hope to see
participants exercising more after the program than they were before. We will also ask them
questions (via the questionnaires) that tell us the degree to which they are exercising based
on their one desires and values, as opposed to doing it because they were told to.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 9, 2019 |
Est. primary completion date | September 9, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Body mass index (BMI) between 25-45 kg/m2 - Report being insufficiently active (i.e., <150 minutes per week of bout related MVPA) Exclusion Criteria: - Unable to engage in physical activity safely due to medical status - Unable to read or understand study materials - Currently in another physical activity or weight control program - Currently taking medications that cause dizziness or feeling faint while standing (e.g., some hypertension medications - Report any condition that would preclude adherence to the intervention protocol (e.g., current or past substance use disorder or psychiatric hospitalization) - Plans to relocate during the study timeline - Terminal illness diagnosis |
Country | Name | City | State |
---|---|---|---|
United States | The Miriam Hospital Weight Control and Diabetes Research Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in bout-related moderate to vigorous physical activity (MVPA) | Average daily minutes spent in objectively measured, bout-related MVPA assessed via a multi-sensor activity monitoring device. | Change from baseline to 3 and 6 months | |
Secondary | Feasibility of the ACT workshop intervention | Successful completion of =70% of email surveys and intervention phone calls | End of 3-month intervention | |
Secondary | Acceptability of the ACT workshop intervention | An adapted, 15-item version of a previous validated feasibility and acceptability measure for PA interventions with a five-point Likert scale (1 = "don't agree at all" to 5 = "totally agree"). Item examples will include, "I enjoyed participating in the intervention," "I think the intervention strategies were appropriate," and, "I found the lessons to be easy to understand." | End of 3-month intervention | |
Secondary | Change in autonomous motivation | Exercise Self-Regulation Questionnaire. A 12-item, Likert scaled ("not true at all" to "very true") measure that assesses why a respondent engages in PA by providing several possible reasons that represent varying degrees of autonomous motivation. | Change from baseline to 3 and 6 months | |
Secondary | Change in values-consistent behavior | Comprehensive Assessment of Acceptance and Commitment Therapy Processes Questionnaire. A 23-item measure with a values subscale that assesses whether individuals are living consistent with their values and what barriers are getting in the way | Change from baseline to 3 and 6 months |
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