Health BehaviorNCT02425384
Accelerometer-linked Online Intervention to Promote Physical Activity in Adolescents
A study testing Intervention Group (motivational website, activity meter) in people with Health Behavior and Adolescent Behavior, run by HopeLab Foundation at 3 sites in United States.
Trial summary
The primary objective of this protocol is to test whether an activity monitor with an online motivational rewards component will increase physical activity levels of middle school-aged students. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Adolescent Behavior, Motivation
- What is being tested?
- Intervention Group (motivational website, activity meter)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Jun 2009
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any student 11 to 14 years old with access to a computer that uses either Windows XP or Mac OS X 10.4 operating system with internet access.
Who cannot join
- Anyone with a medical condition or existing health complications that will interfere with their ability to be physically active.
- Inability to read and write English (though consent forms for parents that speak other languages will be provided).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
West Virginia University
Morgantown, West Virginia, 26506
Crittenden Middle School
Mountain View, California, 94043
Vista Middle School
Vista, California, 92083
About this study
The primary objective of this protocol is to test whether an activity monitor with an online motivational rewards component will increase physical activity levels of middle school-aged students. The secondary objective is to learn about the functionality and utilization of the activity meter device among this age group.
Read the detailed description
The goal of this pilot study is to find out whether an activity meter linked to web-based rewards will increase physical activity levels in middle school aged students who use it over 6 weeks. To test this, students who participate in the study will be assigned to 1 of 3 groups: the meter with web-based rewards group, the Dance Dance Revolution group, or the control group. The physical activity of participants in all 3 groups will be tracked using the an activity meter that participants will be asked to carry daily for the 6 weeks of the study. Participants given the activity meter with web-based rewards or Dance Dance Revolution will be instructed to use them at their own will, as much or as little as they like. Before beginning the study, all participating students will be asked background questions about themselves (such as their gender, age, and ethnic group) and about the kinds of computer and video game consoles they have access to at home. All participants will also complete short questionnaires at enrollment, week 1, week 3 and week 6. These questions will ask participants about their experiences using the assigned devices, their physical activity levels, and their thoughts about their ability to be physically active. At the end of 6 weeks, all participants will finish the study and return their assigned devices to the study coordinator. Height and weight will be measured at baseline and at the end of the study.
- Conditions
- Health Behavior, Adolescent Behavior, Motivation
- Being tested
- Intervention Group (motivational website, activity meter), Active Control (active video game, activity meter), Passive Control (activity meter)
- Keywords
- adolescent, physical activity, accelerometer
- Medical subject headings
- Health Behavior, Adolescent Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group (motivational website, activity meter)Behavioural
The activity meter linked to a motivational website is designed to motivate middle school-aged children to increase their rates of physical activity by providing feedback on the amount of activity, and rewards based on the amount and duration of activity.
Active Control (active video game, activity meter)Behavioural
The active video game, Dance Dance Revolution, requires physical movement as part of game play and may motivate users to engage in more activity. The same activity meter used in the Intervention Group is provided to this group to track physical activity but does not link to the motivational website nor does it provide any feedback on levels or duration of activity.
Passive Control (activity meter)Other
Participants are provided the same activity meter used in the other study groups to track physical activity but it does not link to the motivational website nor does it provide any feedback on levels or duration of activity. Participants are asked to go about their normal activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group is provided an activity meter that tracks the amount and intensity of one's physical activity and is linked to a motivational website. On the website, activity data from the activity meter can be viewed after uploading information from the meter to the website. The reward website allots points for participants based on the amount and intensity of physical activity. Points can be redeemed for rewards on the website, such as gift cards and digital badges. Receives: Behavioral: Intervention Group (motivational website, activity meter) |
| Active Control | Active comparator | This group is provided an activity meter that tracks the amount and intensity of one's physical activity and a copy of the game Dance Dance Revolution (DDR). The activity meter will upload data to a secure server but will not be linked to the motivational website used by the intervention group. DDR is a dancing video game in which players view arrows timed to music on a TV screen and gain points by stepping on the corresponding arrows on a floor mat. Players obtain points in the game by stepping on the correct arrows at the right time to the beat of the music. The points earned with DDR cannot be redeemed for rewards. Receives: Behavioral: Active Control (active video game, activity meter) |
| Passive Control | Placebo comparator | This group is provided with an activity meter and will be asked to carry it with them as they go about their normal daily activities. Like in the Active Control group, participants in the Passive Control group will not have access to the motivational website. For this group, the activity meter functions solely as a monitor to track their activity levels. No other product or intervention will be introduced to the control group. Receives: Other: Passive Control (activity meter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
The amount and intensity of physical activity is recorded continuously every study day that participants wear the provided activity meter for the 6 weeks study. The primary outcome reported will be rates of "moderate to vigorous" physical activity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- HopeLab Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University, Santech, Inc, Stanford University
- Responsible party
- Sponsor
- Investigators
- Steven Cole, PhD, Principal investigator, HopeLab Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425384
- Sponsor's protocol ID
- HL-GD001
- Status last verified
- Apr 2015
- First submitted
- 16 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometer-linked Online Intervention to Promote Physical Activity in Adolescents
- ClinicalTrials.gov ID
- NCT02425384
- Acronym / sponsor ID
- HL-GD001
- Conditions
- Health Behavior, Adolescent Behavior, Motivation
- Keywords
- adolescent, physical activity, accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- HopeLab FoundationUniversity, hospital or other
- Collaborators
- West Virginia University, Santech, Inc, Stanford University
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Apr 2015 (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 primary objective of this protocol is to test whether an activity monitor with an online motivational rewards component will increase physical activity levels of middle school-aged students. The secondary objective is to learn about the functionality and utilization of the activity meter device among this age group.
Detailed description
The goal of this pilot study is to find out whether an activity meter linked to web-based rewards will increase physical activity levels in middle school aged students who use it over 6 weeks. To test this, students who participate in the study will be assigned to 1 of 3 groups: the meter with web-based rewards group, the Dance Dance Revolution group, or the control group. The physical activity of participants in all 3 groups will be tracked using the an activity meter that participants will be asked to carry daily for the 6 weeks of the study. Participants given the activity meter with web-based rewards or Dance Dance Revolution will be instructed to use them at their own will, as much or as little as they like. Before beginning the study, all participating students will be asked background questions about themselves (such as their gender, age, and ethnic group) and about the kinds of computer and video game consoles they have access to at home. All participants will also complete short questionnaires at enrollment, week 1, week 3 and week 6. These questions will ask participants about their experiences using the assigned devices, their physical activity levels, and their thoughts about their ability to be physically active. At the end of 6 weeks, all participants will finish the study and return their assigned devices to the study coordinator. Height and weight will be measured at baseline and at the end of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention Group (motivational website, activity meter)This group is provided an activity meter that tracks the amount and intensity of one's physical activity and is linked to a motivational website. On the website, activity data from the activity meter can be viewed after uploading information from the meter to the website. The reward website allots points for participants based on the amount and intensity of physical activity. Points can be redeemed for rewards on the website, such as gift cards and digital badges. |
| Active Control | Active comparator | Behavioral: Active Control (active video game, activity meter)This group is provided an activity meter that tracks the amount and intensity of one's physical activity and a copy of the game Dance Dance Revolution (DDR). The activity meter will upload data to a secure server but will not be linked to the motivational website used by the intervention group. DDR is a dancing video game in which players view arrows timed to music on a TV screen and gain points by stepping on the corresponding arrows on a floor mat. Players obtain points in the game by stepping on the correct arrows at the right time to the beat of the music. The points earned with DDR cannot be redeemed for rewards. |
| Passive Control | Placebo comparator | Other: Passive Control (activity meter)This group is provided with an activity meter and will be asked to carry it with them as they go about their normal daily activities. Like in the Active Control group, participants in the Passive Control group will not have access to the motivational website. For this group, the activity meter functions solely as a monitor to track their activity levels. No other product or intervention will be introduced to the control group. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any student 11 to 14 years old with access to a computer that uses either Windows XP or Mac OS X 10.4 operating system with internet access.
Key exclusion criteria (2 listed)
- Anyone with a medical condition or existing health complications that will interfere with their ability to be physically active.
- Inability to read and write English (though consent forms for parents that speak other languages will be provided).
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 |
|---|---|---|
| Intervention Group (motivational website, activity meter)The activity meter linked to a motivational website is designed to motivate middle school-aged children to increase their rates of physical activity by providing feedback on the amount of activity, and rewards based on the amount and duration of activity. | Behavioural | Intervention Group |
| Active Control (active video game, activity meter)The active video game, Dance Dance Revolution, requires physical movement as part of game play and may motivate users to engage in more activity. The same activity meter used in the Intervention Group is provided to this group to track physical activity but does not link to the motivational website nor does it provide any feedback on levels or duration of activity. | Behavioural | Active Control |
| Passive Control (activity meter)Participants are provided the same activity meter used in the other study groups to track physical activity but it does not link to the motivational website nor does it provide any feedback on levels or duration of activity. Participants are asked to go about their normal activities. | Other | Passive Control |
Primary outcome
Physical Activity
Time frame: 6 weeks
The amount and intensity of physical activity is recorded continuously every study day that participants wear the provided activity meter for the 6 weeks study. The primary outcome reported will be rates of "moderate to vigorous" physical activity.
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 24 Apr 2015.
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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.
Steven Cole, PhD principal investigator
HopeLab Foundation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (motivational website, activity meter) in people with Health Behavior and Adolescent Behavior, run by HopeLab Foundation at 3 sites 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 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 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 (time frame: 6 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 24 Apr 2015.