Physical InactivityPhase 2NCT01075139
Brief Motivational Intervention to Increase Physical Activity and Fruit/Vegetable Intake
A Phase 2 study testing Brief Motivational Intervention and Educational information in people with Physical Inactivity and Poor Diet, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Research has shown that a high percentage of college students do not meet recommended national guidelines for physical activity or fruit/vegetable intake. The purpose of this study was to pilot test the short-term efficacy of a one-on-one, brief motivational intervention (BMI) designed to increase physical activity… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Poor Diet
- What is being tested?
- Brief Motivational Intervention and Educational information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2009
- Phase
- Phase 2
- 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
- Two or fewer days of 30+ minutes of moderate physical activity per week
- Zero days of 20+ minutes of vigorous physical activity per week
Who cannot join
- Three or more days of 30+ minutes of moderate physical activity per week
- One or more days of 20+ minutes of vigorous physical activity per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of a Brief Motivational Intervention to Increase Physical Activity and Fruit/Vegetable Intake Among College Students
Research has shown that a high percentage of college students do not meet recommended national guidelines for physical activity or fruit/vegetable intake. The purpose of this study was to pilot test the short-term efficacy of a one-on-one, brief motivational intervention (BMI) designed to increase physical activity and fruit/vegetable intake. It was hypothesized that participants in the BMI condition would report greater physical activity and fruit/vegetable intake at follow-up than those in an education-only control condition.
- Conditions
- Physical Inactivity, Poor Diet
- Being tested
- Brief Motivational Intervention, Educational information
- Keywords
- Motivational interviewing, Physical activity, Diet
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionBehavioural
30 minute one-on-one meeting
Educational informationBehavioural
Educational handouts/brochures
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Intervention | Experimental | Subjects in this condition met one-on-one with a counselor for 30 minutes. Subjects received personalized feedback regarding their current physical activity levels and fruit/vegetable intake. Counselors used a motivational interviewing style to try to help resolve ambivalence about changing their current behaviors. Receives: Behavioral: Brief Motivational Intervention |
| Educational information | Active comparator | Subjects in this condition received general educational information about the benefits associated with physical activity and fruit/vegetable intake. Receives: Behavioral: Educational information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vigorous physical activity minutes per week.
Measured: One-month follow-up.
Secondary outcomes (2)
Moderate physical activity minutes per week.
Measured: One-month follow-up.
Fruit and vegetable intake per week
Number of fruit and vegetable servings per day per week
Measured: One-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionOct 2009
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 InactivityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Martens, University of Missouri-Columbia
- Investigators
- Matthew P Martens, Ph.D., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075139
- Sponsor's protocol ID
- N/A (unfunded trial)
- Status last verified
- Sep 2011
- First submitted
- 23 Feb 2010
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Martens MP, Buscemi J, Smith AE, Murphy JG. The short-term efficacy of a brief motivational intervention designed to increase physical activity among college students. J Phys Act Health. 2012 May;9(4):525-32. doi: 10.1123/jpah.9.4.525. Epub 2011 May 12.
PubMed 21934167
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of a Brief Motivational Intervention to Increase Physical Activity and Fruit/Vegetable Intake Among College Students
- ClinicalTrials.gov ID
- NCT01075139
- Acronym / sponsor ID
- N/A (unfunded trial)
- Conditions
- Physical Inactivity, Poor Diet
- Keywords
- Motivational interviewing, Physical activity, Diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Feb 2010 (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.
Research has shown that a high percentage of college students do not meet recommended national guidelines for physical activity or fruit/vegetable intake. The purpose of this study was to pilot test the short-term efficacy of a one-on-one, brief motivational intervention (BMI) designed to increase physical activity and fruit/vegetable intake. It was hypothesized that participants in the BMI condition would report greater physical activity and fruit/vegetable intake at follow-up than those in an education-only control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Intervention | Experimental | Behavioral: Brief Motivational InterventionSubjects in this condition met one-on-one with a counselor for 30 minutes. Subjects received personalized feedback regarding their current physical activity levels and fruit/vegetable intake. Counselors used a motivational interviewing style to try to help resolve ambivalence about changing their current behaviors. |
| Educational information | Active comparator | Behavioral: Educational informationSubjects in this condition received general educational information about the benefits associated with physical activity and fruit/vegetable intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Two or fewer days of 30+ minutes of moderate physical activity per week
- Zero days of 20+ minutes of vigorous physical activity per week
Key exclusion criteria (2 listed)
- Three or more days of 30+ minutes of moderate physical activity per week
- One or more days of 20+ minutes of vigorous physical activity per week
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 |
|---|---|---|
| Brief Motivational Intervention30 minute one-on-one meeting | Behavioural | Brief Motivational Intervention |
| Educational informationEducational handouts/brochures | Behavioural | Educational information |
Primary outcome
Vigorous physical activity minutes per week.
Time frame: One-month follow-up.
2 secondary outcomes
Moderate physical activity minutes per week.
Time frame: One-month follow-up.
Fruit and vegetable intake per week
Time frame: One-month follow-up
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 22 Sep 2011.
- Derived from this study: PubMed 21934167Martens MP, Buscemi J, Smith AE, Murphy JG. The short-term efficacy of a brief motivational intervention designed to increase physical activity among college students. J Phys Act Health. 2012 May;9(4):525-32. doi: 10.1123/jpah.9.4.525. Epub 2011 May 12.
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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.
Matthew P Martens, Ph.D. principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brief Motivational Intervention and Educational information in people with Physical Inactivity and Poor Diet, run by University of Missouri-Columbia 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 2 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 22 Sep 2011. 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.
What does this 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.
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?
Vigorous physical activity minutes per week. (time frame: One-month follow-up.). 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 NCT01075139, 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 22 Sep 2011.