Physical ActivityEVOLVENCT03565731
Exercise Values of Life and Vitality Everyday
A study testing ACT-PA in people with Physical Activity and Lifestyle, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Lifestyle, Behavior
- What is being tested?
- ACT-PA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 9 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 25-45 kg/m2
- Report being insufficiently active (i.e., <150 minutes per week of bout related MVPA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: A Novel Behavioral Approach for the Adoption and Maintenance of Habitual Physical Activity
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.
Read the detailed description
Despite the importance of adoption and maintenance of habitual moderate to vigorous-intensity physical activity (MVPA) for health benefits and long-term weight management, current comprehensive lifestyle interventions place little emphasis on physical activity behavior change strategies and have only modest impact on MVPA. Acceptance and Commitment Therapy (ACT), a well validated, newer generation behavioral approach uses values of clarification and commitment strategies, along with acceptance-based skills training, to effect health behavior change that is consistent with personally identified values. ACT presents a theoretically consistent and potentially powerful intervention framework from which to target values-based autonomous motivation and increase MVPA. The overall aim of this study is to test the feasibility, acceptability, and preliminary efficacy of an ACT-based workshop intervention for increasing bout-related MVPA for overweight and obese, insufficiently active adults using a single-arm design. We will recruit 48 overweight/obese, insufficiently active adults across multiple cohorts and provide them with a 4-hour, ACT-based workshop followed by weekly emails and monthly phone calls for 3 months. The primary goal of the workshop is to use values clarification and acceptance-based skills training to increase values-based autonomous motivation and bout-related MVPA. Participants will self-monitor and report on progress via weekly emails and monthly phone calls. Assessments will be at baseline, 3, and 6 months. The goal of this study is threefold: 1) to determine the feasibility and acceptability of the ACT workshop intervention by assessing the completion of the intervention at all time points and via questionnaires; 2) to show changes in autonomous motivation and values-consistent behavior at the end of the intervention; and 3) to show changes in physical activity, by use of an objectively measured physical activity devices, where participants are engaging in at least 200 minutes of MVPA at 3 and 6-months)
This study will be conducted at the Miriam Hospital Weight Control and Diabetes Research Center by Drs. Jason Lillis and Dale Bond.
- Conditions
- Physical Activity, Lifestyle, Behavior, Lifestyle, Sedentary, Acceptance and Commitment Therapy, Exercise
- Being tested
- ACT-PA
- Medical subject headings
- Motor Activity, Behavior, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-PABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT-PA Intervention | Experimental | The 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. Receives: Behavioral: ACT-PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 3 and 6 months
Secondary outcomes (4)
Feasibility of the ACT workshop intervention
Successful completion of ≥70% of email surveys and intervention phone calls
Measured: End of 3-month intervention
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."
Measured: End of 3-month intervention
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.
Measured: Change from baseline to 3 and 6 months
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
Measured: Change from baseline to 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start8 Mar 2018
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565731
- Sponsor's protocol ID
- 2059-17
- Other IDs
- 1R03DK114254
- Acronym
- EVOLVE
- Status last verified
- Jun 2020
- First submitted
- 19 Dec 2017
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30782749
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Behavioral Approach for the Adoption and Maintenance of Habitual Physical Activity
- ClinicalTrials.gov ID
- NCT03565731
- Acronym / sponsor ID
- EVOLVE / 2059-17
- Conditions
- Physical Activity, Lifestyle, Behavior, Lifestyle, Sedentary, Acceptance and Commitment Therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite the importance of adoption and maintenance of habitual moderate to vigorous-intensity physical activity (MVPA) for health benefits and long-term weight management, current comprehensive lifestyle interventions place little emphasis on physical activity behavior change strategies and have only modest impact on MVPA. Acceptance and Commitment Therapy (ACT), a well validated, newer generation behavioral approach uses values of clarification and commitment strategies, along with acceptance-based skills training, to effect health behavior change that is consistent with personally identified values. ACT presents a theoretically consistent and potentially powerful intervention framework from which to target values-based autonomous motivation and increase MVPA. The overall aim of this study is to test the feasibility, acceptability, and preliminary efficacy of an ACT-based workshop intervention for increasing bout-related MVPA for overweight and obese, insufficiently active adults using a single-arm design. We will recruit 48 overweight/obese, insufficiently active adults across multiple cohorts and provide them with a 4-hour, ACT-based workshop followed by weekly emails and monthly phone calls for 3 months. The primary goal of the workshop is to use values clarification and acceptance-based skills training to increase values-based autonomous motivation and bout-related MVPA. Participants will self-monitor and report on progress via weekly emails and monthly phone calls. Assessments will be at baseline, 3, and 6 months. The goal of this study is threefold: 1) to determine the feasibility and acceptability of the ACT workshop intervention by assessing the completion of the intervention at all time points and via questionnaires; 2) to show changes in autonomous motivation and values-consistent behavior at the end of the intervention; and 3) to show changes in physical activity, by use of an objectively measured physical activity devices, where participants are engaging in at least 200 minutes of MVPA at 3 and 6-months)
This study will be conducted at the Miriam Hospital Weight Control and Diabetes Research Center by Drs. Jason Lillis and Dale Bond.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT-PA Intervention | Experimental | Behavioral: ACT-PAThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 25-45 kg/m2
- Report being insufficiently active (i.e., <150 minutes per week of bout related MVPA)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-PAThe 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. | Behavioural | ACT-PA Intervention |
Primary outcome
Change in bout-related moderate to vigorous physical activity (MVPA)
Time frame: Change from baseline to 3 and 6 months
Average daily minutes spent in objectively measured, bout-related MVPA assessed via a multi-sensor activity monitoring device.
4 secondary outcomes
Feasibility of the ACT workshop intervention
Time frame: End of 3-month intervention
Acceptability of the ACT workshop intervention
Time frame: End of 3-month intervention
Change in autonomous motivation
Time frame: Change from baseline to 3 and 6 months
Change in values-consistent behavior
Time frame: Change from baseline to 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 30782749Lillis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-PA in people with Physical Activity and Lifestyle, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bout-related moderate to vigorous physical activity (MVPA) (time frame: Change from baseline to 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.