Physical ActivityPhase 2NCT01033253
Multi-media Obesity Prevention Program for Adolescents
A Phase 2 study testing Health in Motion in people with Physical Activity and Nutrition, run by Pro-Change Behavior Systems at 1 site in United States.
Trial summary
The objective of this project was to evaluate a population-based, computerized tailored intervention that addresses recommended guidelines for three target behaviors related to obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and vegetable consumption (at least 5 servings of… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Nutrition, Obesity Prevention
- What is being tested?
- Health in Motion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2008
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- English speaking
- In the 9th, 10th, or 11th grade at baseline
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Pro-Change Behavior Systems, Inc.
Kingston, Rhode Island, 02892
About this study
The objective of this project was to evaluate a population-based, computerized tailored intervention that addresses recommended guidelines for three target behaviors related to obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and vegetable consumption (at least 5 servings of fruits and vegetables each day), and limited TV viewing (2 hours or less of TV each day).
- Conditions
- Physical Activity, Nutrition, Obesity Prevention
- Being tested
- Health in Motion
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health in MotionBehavioural
Students interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages. A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed. Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing. These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior. Multimedia components, including audio, video, and animations helped to capture students' interest.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Tailored Intervention | Experimental | Students interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages. A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed. Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing. These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior. Multimedia components, including audio, video, and animations helped to capture students' interest. Receives: Behavioral: Health in Motion |
| Control | No intervention | Computerized assessments of Transtheoretical Model constructs at 0, 2, 6, and 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days per week for which students got at least 60 minutes of physical activity
Measured: 2, 6, and 12 months
The number of servings of fruits and vegetables consumed each day
Measured: 2, 6, and 12 months
The number of hours of TV watch each day, including time spent watching TV, videotapes, and DVD's
Measured: 2, 6, and 12 months
Secondary outcomes (3)
Stage of change for readiness to do at least 60 minutes of physical activity on at least 5 days of the week
Measured: 2, 6, and 12 months
Stage of change for readiness to eat at least five servings of fruits and vegetables each day.
Measured: 2, 6, and 12 months
Stage of change for readiness to watch two hours or less of TV each day.
Measured: 2, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Investigators
- Leanne Mauriello, Ph.D., Principal investigator, Pro-Change Behavior Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033253
- Sponsor's protocol ID
- R44HL074482-02
- Status last verified
- Dec 2009
- First submitted
- 14 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Driskell MM, Dyment S, Mauriello L, Castle P, Sherman K. Relationships among multiple behaviors for childhood and adolescent obesity prevention. Prev Med. 2008 Mar;46(3):209-15. doi: 10.1016/j.ypmed.2007.07.028. Epub 2007 Aug 1.
PubMed 17714771Mauriello LM, Driskell MM, Sherman KJ, Johnson SS, Prochaska JM, Prochaska JO. Acceptability of a school-based intervention for the prevention of adolescent obesity. J Sch Nurs. 2006 Oct;22(5):269-77. doi: 10.1177/10598405060220050501.
PubMed 17172199Mauriello LM, Sherman KJ, Driskell MM, Prochaska JM. Using interactive behavior change technology to intervene on physical activity and nutrition with adolescents. Adolesc Med State Art Rev. 2007 Aug;18(2):383-99, xiii.
PubMed 18605653
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-media Obesity Prevention Program for Adolescents
- ClinicalTrials.gov ID
- NCT01033253
- Acronym / sponsor ID
- R44HL074482-02
- Conditions
- Physical Activity, Nutrition, Obesity Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Dec 2009 (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 objective of this project was to evaluate a population-based, computerized tailored intervention that addresses recommended guidelines for three target behaviors related to obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and vegetable consumption (at least 5 servings of fruits and vegetables each day), and limited TV viewing (2 hours or less of TV each day).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Tailored Intervention | Experimental | Behavioral: Health in MotionStudents interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages. A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed. Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing. These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior. Multimedia components, including audio, video, and animations helped to capture students' interest. |
| Control | No intervention | –Computerized assessments of Transtheoretical Model constructs at 0, 2, 6, and 12 months |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- English speaking
- In the 9th, 10th, or 11th grade at baseline
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Health in MotionStudents interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages. A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed. Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing. These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior. Multimedia components, including audio, video, and animations helped to capture students' interest. | Behavioural | Computerized Tailored Intervention |
Primary outcome
The number of days per week for which students got at least 60 minutes of physical activity
Time frame: 2, 6, and 12 months
The number of servings of fruits and vegetables consumed each day
Time frame: 2, 6, and 12 months
The number of hours of TV watch each day, including time spent watching TV, videotapes, and DVD's
Time frame: 2, 6, and 12 months
3 secondary outcomes
Stage of change for readiness to do at least 60 minutes of physical activity on at least 5 days of the week
Time frame: 2, 6, and 12 months
Stage of change for readiness to eat at least five servings of fruits and vegetables each day.
Time frame: 2, 6, and 12 months
Stage of change for readiness to watch two hours or less of TV each day.
Time frame: 2, 6, and 12 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 16 Dec 2009.
- Background: PubMed 17714771Driskell MM, Dyment S, Mauriello L, Castle P, Sherman K. Relationships among multiple behaviors for childhood and adolescent obesity prevention. Prev Med. 2008 Mar;46(3):209-15. doi: 10.1016/j.ypmed.2007.07.028. Epub 2007 Aug 1.
- Background: PubMed 17172199Mauriello LM, Driskell MM, Sherman KJ, Johnson SS, Prochaska JM, Prochaska JO. Acceptability of a school-based intervention for the prevention of adolescent obesity. J Sch Nurs. 2006 Oct;22(5):269-77. doi: 10.1177/10598405060220050501.
- Background: PubMed 18605653Mauriello LM, Sherman KJ, Driskell MM, Prochaska JM. Using interactive behavior change technology to intervene on physical activity and nutrition with adolescents. Adolesc Med State Art Rev. 2007 Aug;18(2):383-99, xiii.
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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.
Leanne Mauriello, Ph.D. principal investigator
Pro-Change Behavior Systems
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 Health in Motion in people with Physical Activity and Nutrition, run by Pro-Change Behavior Systems 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 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 16 Dec 2009. 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?
The number of days per week for which students got at least 60 minutes of physical activity (time frame: 2, 6, and 12 months). The study lists 3 primary outcomes in all. 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 NCT01033253, which also lists 3 linked publications.
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 16 Dec 2009.