Exercise PromotionPhase 2/3NCT02250950
An Examination of the Efficacy of a Self-Determination Theory and Motivational Interviewing Exercise Intervention
A Phase 2/3 study testing MI and SDT Exercise Group and Non-MI and SDT Exercise Group in people with Exercise Promotion, run by Syracuse University at 1 site in United States.
Trial summary
The current study involves conducting an intervention based on self-determination theory (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise Promotion
- What is being tested?
- MI and SDT Exercise Group and Non-MI and SDT Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Feb 2015
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants were were willing to attend an exercise class once a week for 12 weeks, were willing to complete questionnaires at baseline and 12 weeks, allowed the intervention staff to monitor their attendance at the YMCA for 6 months post intervention, and allowed the exercise instructor to create an audio recording of all of the intervention sessions.
Who cannot join
- not have any illnesses that would prevent them from exercising once a week, not be pregnant or planning to get pregnant within the next 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Disparities in Physical Activity: An Intervention Based on Self-Determination Theory and Motivational Interviewing
The current study involves conducting an intervention based on self-determination theory (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants.
Read the detailed description
The mental and physical benefits of physical activity are well-established. However, there is a racial disparity in exercise, such that minorities are much less likely to engage in physical activity than are white individuals. Research suggests that a lack of motivation may be an important barrier to physical activity for racial minorities. Therefore, interventions which increase participants' motivation may be especially useful in promoting physical activity within these groups. A previous meta-analysis has found that physical activity interventions based on self-determination theory (SDT) and motivational interviewing (MI) are especially effective in increasing white individuals' physical activity (Miller \& Gramzow, under review). However, it remains unclear the extent to which these results apply to minority populations. The current study involves conducting an intervention based on SDT and MI to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants. Specifically, it is expected that there will be a greater relative increase in physical activity in minority individuals than white individuals within the intervention group because it is expected that their level of activity will be lower at baseline.
- Conditions
- Exercise Promotion
- Being tested
- MI and SDT Exercise Group, Non-MI and SDT Exercise Group
- Keywords
- self-determination theory, motivational interviewing, exercise, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI and SDT Exercise GroupBehavioural
The intervention group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor trained in MI and SDT. This individual will lead group discussions and will have the participants exercise together.
Non-MI and SDT Exercise GroupBehavioural
This group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor who was not trained in MI and SDT. This individual will lead a regular exercise class.
| Study group | Role | What they receive |
|---|---|---|
| MI and SDT Exercise Group | Experimental | Intervention Condition: Participated in 12 weekly meetings led by MI- and SDT-trained exercise instructor. Receives: Behavioral: MI and SDT Exercise Group |
| Non-MI and SDT Exercise Group | Sham comparator | Control Condition: Participated in 12 weekly meetings led by an exercise instructor who was not trained in MI and SDT. Receives: Behavioral: Non-MI and SDT Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire
Measured: 12 weeks
Secondary outcomes (4)
Psychological General Well-Being Index
Measured: 12 weeks
Basic Psychological Needs in Exercise Scale
Measured: 12 weeks
Behavioural Regulation in Exercise Questionnaire
Measured: 12 weeks
Physical Activity Adherence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 Exercise PromotionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Miller, Syracuse University
- Investigators
- Lauren S Miller, M.S., Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250950
- Sponsor's protocol ID
- 4636
- Status last verified
- May 2015
- First submitted
- 24 Sep 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miller LS, Gramzow RH. A self-determination theory and motivational interviewing intervention to decrease racial/ethnic disparities in physical activity: rationale and design. BMC Public Health. 2016 Aug 11;16(1):768. doi: 10.1186/s12889-016-3413-2.
PubMed 27515173
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Disparities in Physical Activity: An Intervention Based on Self-Determination Theory and Motivational Interviewing
- ClinicalTrials.gov ID
- NCT02250950
- Acronym / sponsor ID
- 4636
- Conditions
- Exercise Promotion
- Keywords
- self-determination theory, motivational interviewing, exercise, physical activity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Sep 2014 (estimated)
- 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 current study involves conducting an intervention based on self-determination theory (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants.
Detailed description
The mental and physical benefits of physical activity are well-established. However, there is a racial disparity in exercise, such that minorities are much less likely to engage in physical activity than are white individuals. Research suggests that a lack of motivation may be an important barrier to physical activity for racial minorities. Therefore, interventions which increase participants' motivation may be especially useful in promoting physical activity within these groups. A previous meta-analysis has found that physical activity interventions based on self-determination theory (SDT) and motivational interviewing (MI) are especially effective in increasing white individuals' physical activity (Miller \& Gramzow, under review). However, it remains unclear the extent to which these results apply to minority populations. The current study involves conducting an intervention based on SDT and MI to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants. Specifically, it is expected that there will be a greater relative increase in physical activity in minority individuals than white individuals within the intervention group because it is expected that their level of activity will be lower at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI and SDT Exercise Group | Experimental | Behavioral: MI and SDT Exercise GroupIntervention Condition: Participated in 12 weekly meetings led by MI- and SDT-trained exercise instructor. |
| Non-MI and SDT Exercise Group | Sham comparator | Behavioral: Non-MI and SDT Exercise GroupControl Condition: Participated in 12 weekly meetings led by an exercise instructor who was not trained in MI and SDT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants were were willing to attend an exercise class once a week for 12 weeks, were willing to complete questionnaires at baseline and 12 weeks, allowed the intervention staff to monitor their attendance at the YMCA for 6 months post intervention, and allowed the exercise instructor to create an audio recording of all of the intervention sessions.
Key exclusion criteria (1 listed)
- not have any illnesses that would prevent them from exercising once a week, not be pregnant or planning to get pregnant within the next 3 months
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 |
|---|---|---|
| MI and SDT Exercise GroupThe intervention group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor trained in MI and SDT. This individual will lead group discussions and will have the participants exercise together. | Behavioural | MI and SDT Exercise Group |
| Non-MI and SDT Exercise GroupThis group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor who was not trained in MI and SDT. This individual will lead a regular exercise class. | Behavioural | Non-MI and SDT Exercise Group |
Primary outcome
International Physical Activity Questionnaire
Time frame: 12 weeks
4 secondary outcomes
Psychological General Well-Being Index
Time frame: 12 weeks
Basic Psychological Needs in Exercise Scale
Time frame: 12 weeks
Behavioural Regulation in Exercise Questionnaire
Time frame: 12 weeks
Physical Activity Adherence
Time frame: 12 weeks
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 19 May 2015.
- Derived from this study: PubMed 27515173Miller LS, Gramzow RH. A self-determination theory and motivational interviewing intervention to decrease racial/ethnic disparities in physical activity: rationale and design. BMC Public Health. 2016 Aug 11;16(1):768. doi: 10.1186/s12889-016-3413-2.
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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.
Lauren S Miller, M.S. principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MI and SDT Exercise Group and Non-MI and SDT Exercise Group in people with Exercise Promotion, run by Syracuse University 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 1 inclusion and 1 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 19 May 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
International Physical Activity Questionnaire (time frame: 12 weeks). 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 NCT02250950, 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 19 May 2015.