Health BehaviorNCT01412099
Nutrition and Physical Activity Counseling for Nontraditional College Students
A study testing peer counseling and Feedback report in people with Health Behavior, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effectiveness of two methods of delivering information about nutrition and physical activity to non-traditional college students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- peer counseling and Feedback report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently enrolled undergraduate student at UMass Boston,
- Have completed high school,
- 24yrs old or older AND/OR part time students,
- Noncompliant in at least 1 of 4 behaviors: fruit \& vegetable intake, sugar sweetened beverage intake, fast food intake, or physical activity),
- Willing to randomized into either study group,
- Be able to give informed consent.
Who cannot join
- Have any contraindications to physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Boston
Boston, Massachusetts, 02125
About this study
Official title: Feasibility of a Health Promotion Program for Nontraditional College Students
The purpose of this research study is to evaluate the effectiveness of two methods of delivering information about nutrition and physical activity to non-traditional college students. Participants will receive either a printed feedback report alone, or the feedback report in addition to a series of phone calls from a peer counselor. The peer counselors will provide nutrition and physical activity counseling using motivational interviewing techniques. Nutrition and physical activity outcomes will be measured for both groups and compared.
- Conditions
- Health Behavior
- Being tested
- peer counseling, Feedback report
- Keywords
- Exercise, Fast Foods, Fruits, Vegetables, Beverages, Non-traditional college students, Motivational Interviewing, Peer Counselors, Cancer Prevention
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer counselingBehavioural
Participants receive 3 phone calls from a peer counselor to deliver counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 6 week period.
Feedback reportBehavioural
Participants receive a one-page printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Feedback report plus peer counseling | Experimental | Not described Receives: Behavioral: peer counseling; Behavioral: Feedback report |
| Feedback report | Experimental | Not described Receives: Behavioral: Feedback report |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity and diet behaviors (fruit and vegetable intake, sugary drink intake, and fast food intake)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa M. Quintiliani, Boston Medical Center
- Investigators
- Lisa M Quinitiliani, PhD, RD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412099
- Sponsor's protocol ID
- 1R03CA139943
- Other IDs
- NCI-2011-00671
- Status last verified
- Feb 2012
- First submitted
- 5 Aug 2011
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Health Promotion Program for Nontraditional College Students
- ClinicalTrials.gov ID
- NCT01412099
- Acronym / sponsor ID
- 1R03CA139943
- Conditions
- Health Behavior
- Keywords
- Exercise, Fast Foods, Fruits, Vegetables, Beverages, Non-traditional college students, Motivational Interviewing, Peer Counselors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Aug 2011 (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 purpose of this research study is to evaluate the effectiveness of two methods of delivering information about nutrition and physical activity to non-traditional college students. Participants will receive either a printed feedback report alone, or the feedback report in addition to a series of phone calls from a peer counselor. The peer counselors will provide nutrition and physical activity counseling using motivational interviewing techniques. Nutrition and physical activity outcomes will be measured for both groups and compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback report plus peer counseling | Experimental | Behavioral: peer counseling, Behavioral: Feedback report |
| Feedback report | Experimental | Behavioral: Feedback report |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently enrolled undergraduate student at UMass Boston,
- Have completed high school,
- 24yrs old or older AND/OR part time students,
- Noncompliant in at least 1 of 4 behaviors: fruit \& vegetable intake, sugar sweetened beverage intake, fast food intake, or physical activity),
- Willing to randomized into either study group,
Key exclusion criteria (1 listed)
- Have any contraindications to physical activity
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 |
|---|---|---|
| peer counselingParticipants receive 3 phone calls from a peer counselor to deliver counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 6 week period. | Behavioural | Feedback report plus peer counseling |
| Feedback reportParticipants receive a one-page printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines. | Behavioural | Feedback report, Feedback report plus peer counseling |
Primary outcome
physical activity and diet behaviors (fruit and vegetable intake, sugary drink intake, and fast food intake)
Time frame: 8 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 6 Feb 2012.
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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.
Lisa M Quinitiliani, PhD, RD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer counseling and Feedback report in people with Health Behavior, run by Boston Medical Center 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 6 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 6 Feb 2012. 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?
physical activity and diet behaviors (fruit and vegetable intake, sugary drink intake, and fast food intake) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2012.