Exercise Values of Life and Vitality Everyday
EVOLVE
A Novel Behavioral Approach for the Adoption and Maintenance of Habitual Physical Activity
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2017
CompletedStudy Start
First participant enrolled
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2019
CompletedJune 11, 2020
June 1, 2020
1.5 years
December 19, 2017
June 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Feasibility of the ACT workshop intervention
End of 3-month intervention
Acceptability of the ACT workshop intervention
End of 3-month intervention
Change in autonomous motivation
Change from baseline to 3 and 6 months
Change in values-consistent behavior
Change from baseline to 3 and 6 months
Study Arms (1)
ACT-PA Intervention
EXPERIMENTALThe primary goal of the intervention is to increase values-based autonomous motivation to increase bout-related MVPA using a single workshop. Participants will engage in basic and advanced values clarification exercise to help clarify (1) the relative importance of major values domains (e.g. social, vocational, recreational), and (2) the potential role of PA in empowering functioning in these domains. Participants will generate their own activity goals and additional values-based goals. In addition, acceptance strategies will be taught to reduce cognitive and emotional barriers to meeting values-based goals. Participants will be asked to report progress on goals each week via an automated email survey from a secure project website. Upon completing the survey, participants will receive standardized responses via email. Monthly phone calls will be brief, semi-structured, and designed to review key principles and trouble-shoot specific barriers identified by the participant.
Interventions
The overall goal of the intervention is to increase bout-related moderate-to-vigorous physical (MVPA) activity to greater than 200 minutes per week. The basic structure is an initial on-site, group-based intervention workshop, written materials, weekly emails, and monthly phone calls for a total of 3 months.
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 25-45 kg/m2
- Report being insufficiently active (i.e., \<150 minutes per week of bout related MVPA)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Miriam Hospital Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903, United States
Related Publications (1)
Lillis J, Bond DS. Values-based and acceptance-based intervention to promote adoption and maintenance of habitual physical activity among inactive adults with overweight/obesity: a study protocol for an open trial. BMJ Open. 2019 Jan 9;9(1):e025115. doi: 10.1136/bmjopen-2018-025115.
PMID: 30782749DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2017
First Posted
June 21, 2018
Study Start
March 8, 2018
Primary Completion
September 9, 2019
Study Completion
September 9, 2019
Last Updated
June 11, 2020
Record last verified: 2020-06