Health BehaviorNCT01433679
The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents
A study testing Zamzee Intervention in people with Health Behavior and Adolescent Behavior, run by HopeLab Foundation at 6 sites in United States.
Trial summary
The primary purpose of this study is to test whether rewarding physical activity with a motivational website will increase physical activity levels in middle school-aged children over six months. 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?
- Zamzee Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2011to Jul 2012
- 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
- Middle-school-aged students aged 11 to 14
Who cannot join
- Previously participation in a Zamzee pilot study
- Existing medical conditions or health complications that will interfere with the ability to be physically active
- Inability to read and write English
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Los Osos Middle School
Los Osos, California, 93402
West Virginia University
Morgantown, West Virginia, 26506-6845
Berkley Maynard Academy
Oakland, California, 94605
E.C. Reems Academy
Oakland, California, 94605
Judkins Middle School
Pismo Beach, California, 93449
Vista Academy of Visual and Performing Arts
Vista, California, 92083
About this study
The primary purpose of this study is to test whether rewarding physical activity with a motivational website will increase physical activity levels in middle school-aged children over six months. As a secondary outcome, the study also tests the intervention's impact on biological measures of inflammation and metabolic function in a sub-set of study participants who agree to provide blood samples.
Read the detailed description
Physical activity is associated with a variety of positive health outcomes, as well as improved metabolic profiles and reduced inflammation. However, levels of moderate to vigorous physical activity (MVPA) diminish dramatically as children move into the middle school years. To address this problem, this study tests a behavioral intervention, called "Zamzee," designed to motivate middle school-aged children to increase their levels of MVPA. The Zamzee intervention consists of a 3-axis accelerometer that tracks individual physical activity rates over time and a website that displays individual physical activity rates and provides rewards for maintaining or improving physical activity rates. The primary aim of this randomized, controlled trial is to test whether middle school-aged children randomly assigned to the Zamzee intervention will show significantly greater levels of physical activity levels over six months, compared with control group participants who wear the accelerometer but have no access to the rewards website. A secondary aim is to test the intervention's impact on biological parameters that may contribute to the long-term health effects of inactivity (including C-reactive protein as a measure of inflammation, and hemoglobin-A1C as a measure of metabolic status) in a sub-set of study participants who agree to provide blood samples.
- Conditions
- Health Behavior, Adolescent Behavior, Motivation
- Being tested
- Zamzee Intervention
- Keywords
- Health Behavior, Exercise, Adolescent Behavior, Motivation, Biological Markers
- 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.
Zamzee InterventionBehavioural
The Zamzee intervention is designed to motivate middle school-aged children to increase their rates of moderate to vigorous physical activity (MVPA) by providing rewards based on amount and duration of physical activity. Rewards include gift cards to retail stores, donations to charity, small tangible goods, and customization of their cartoon-like avatars on the website.
| Study group | Role | What they receive |
|---|---|---|
| Website intervention | Experimental | Participants randomly assigned to the Website Intervention arm receive access to the motivational rewards website. The website displays the individual's physical activity data and allocates reward points based on the amount and intensity of physical activity. The website also allows reward points to be redeemed for various rewards such as gift cards to retail outlets, donations to charities, small tangible goods, and customization of participants' cartoon-like avatars on the website. Receives: Behavioral: Zamzee Intervention |
| Control | No intervention | Participants in the control group will not have access to the motivational website. No other product or intervention will be introduced to the control group. |
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 their accelerometer for the duration of the six month study. The primary outcome reported will be rates of "moderate to vigorous physical activity" as defined by the CDC.
Measured: Six months
Secondary outcomes (1)
Metabolic and inflammatory biomarkers
In the subset of study participants who agree to provide blood samples, blood samples collected at study baseline and at the six month study completion will be assayed for measures of inflammation (e.g., C-reactive protein) and metabolic function (e.g.,hemoglobin-A1C).
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionJul 2012
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- HopeLab Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University
- Responsible party
- Sponsor
- Investigators
- Jana Haritatos, PhD, Principal investigator, HopeLab FoundationSteve Cole, PhD, Study director, HopeLab Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433679
- Sponsor's protocol ID
- HLZZ-001
- Status last verified
- Jul 2012
- First submitted
- 12 Sep 2011
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents
- ClinicalTrials.gov ID
- NCT01433679
- Acronym / sponsor ID
- HLZZ-001
- Conditions
- Health Behavior, Adolescent Behavior, Motivation
- Keywords
- Health Behavior, Exercise, Adolescent Behavior, Motivation, Biological Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- HopeLab FoundationUniversity, hospital or other
- Collaborators
- West Virginia University
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Sep 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 primary purpose of this study is to test whether rewarding physical activity with a motivational website will increase physical activity levels in middle school-aged children over six months. As a secondary outcome, the study also tests the intervention's impact on biological measures of inflammation and metabolic function in a sub-set of study participants who agree to provide blood samples.
Detailed description
Physical activity is associated with a variety of positive health outcomes, as well as improved metabolic profiles and reduced inflammation. However, levels of moderate to vigorous physical activity (MVPA) diminish dramatically as children move into the middle school years. To address this problem, this study tests a behavioral intervention, called "Zamzee," designed to motivate middle school-aged children to increase their levels of MVPA. The Zamzee intervention consists of a 3-axis accelerometer that tracks individual physical activity rates over time and a website that displays individual physical activity rates and provides rewards for maintaining or improving physical activity rates. The primary aim of this randomized, controlled trial is to test whether middle school-aged children randomly assigned to the Zamzee intervention will show significantly greater levels of physical activity levels over six months, compared with control group participants who wear the accelerometer but have no access to the rewards website. A secondary aim is to test the intervention's impact on biological parameters that may contribute to the long-term health effects of inactivity (including C-reactive protein as a measure of inflammation, and hemoglobin-A1C as a measure of metabolic status) in a sub-set of study participants who agree to provide blood samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Website intervention | Experimental | Behavioral: Zamzee InterventionParticipants randomly assigned to the Website Intervention arm receive access to the motivational rewards website. The website displays the individual's physical activity data and allocates reward points based on the amount and intensity of physical activity. The website also allows reward points to be redeemed for various rewards such as gift cards to retail outlets, donations to charities, small tangible goods, and customization of participants' cartoon-like avatars on the website. |
| Control | No intervention | –Participants in the control group will not have access to the motivational website. 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)
- Middle-school-aged students aged 11 to 14
Key exclusion criteria (3 listed)
- Previously participation in a Zamzee pilot study
- Existing medical conditions or health complications that will interfere with the ability to be physically active
- Inability to read and write English
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 |
|---|---|---|
| Zamzee InterventionThe Zamzee intervention is designed to motivate middle school-aged children to increase their rates of moderate to vigorous physical activity (MVPA) by providing rewards based on amount and duration of physical activity. Rewards include gift cards to retail stores, donations to charity, small tangible goods, and customization of their cartoon-like avatars on the website. | Behavioural | Website intervention |
Primary outcome
Physical activity
Time frame: Six months
The amount and intensity of physical activity is recorded continuously every study day that participants wear their accelerometer for the duration of the six month study. The primary outcome reported will be rates of "moderate to vigorous physical activity" as defined by the CDC.
1 secondary outcome
Metabolic and inflammatory biomarkers
Time frame: Six 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 Jul 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.
Jana Haritatos, PhD principal investigator
HopeLab Foundation
Steve Cole, PhD study director
HopeLab Foundation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zamzee Intervention in people with Health Behavior and Adolescent Behavior, run by HopeLab Foundation at 6 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 3 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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: Six months). 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 16 Jul 2012.