HealthyPhase 2WEBABCNCT00961246
Web-Based Active Balance Childhood Study in Chinese-American
A Phase 2 study testing general health information and individually-tailored intervention in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study compares the feasibility and efficacy of an individually tailored, child-centered, Internet-based behavioral intervention with that of general Internet-based health information for improving health behaviors and relative weight in Chinese-American children during a 6-month period. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- general health information and individually-tailored intervention
- 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
- Mar 2008to May 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- children between the ages of 10 and 14 years old who self-identify as Chinese or of Chinese origin
- reside in the Bay Area in the same household as at least one parent, can read and speak English, and have access to the Internet at home
- Parents:
- parents who self-identify as Chinese or of Chinese origin
- have children between the ages of 11 and 14
Show all 9Show fewer
- are able to read either Chinese or English
- are able to speak Mandarin, Cantonese, or English
- have access to the Internet at home
Who cannot join
- children with chronic health problems that include any dietary modifications or activity limitations will be excluded (e.g., diabetes, exercise-induced asthma)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Web-Based Active Balance Childhood Study in Chinese-American (Web ABC Study): A Randomized Clinical Trial
This study compares the feasibility and efficacy of an individually tailored, child-centered, Internet-based behavioral intervention with that of general Internet-based health information for improving health behaviors and relative weight in Chinese-American children during a 6-month period. A total of 60 children (age 10-14) and their families will be randomized to either the intervention group or control group. The intervention is based on the Social Cognitive Theory and Transtheoretical Model.
Read the detailed description
The proposed study will use a randomized experimental design to examine the effects of an individually tailored, Internet-based behavioral intervention program on improving health behavior (dietary intake and physical activity) and anthropometrics of Chinese-American children. A total of 60 children and their families will be recruited. The intervention will include a weekly Internet session tailored to each individual child for eight weeks and three Internet sessions for parents. Children and their parents in the control group will receive general health information on healthy eating, active lifestyles, dental care, smoking cessation, and risk taking issues via the Internet. The content of the sessions is described later. After informed consent is obtained from parents and verbal assent from the children, baseline data (T0) will be collected before assigning the children and parents to the intervention group or control group. Follow-up data for both groups will be collected at 2 months (T1), 4 months (T2) and 6 months (T3) after baseline.
- Conditions
- Healthy
- Being tested
- general health information, individually-tailored intervention
- Keywords
- web based intervention, individually-tailored, Chinese-American children, compared the changes in physical activity level, changes in dietary intake, changes in coping strategy used, changes in BMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general health informationBehavioural
participants received general health information
individually-tailored interventionBehavioural
participants received individually-tailored intervention
| Study group | Role | What they receive |
|---|---|---|
| general health information group | Active comparator | participants received general health information Receives: Behavioral: general health information |
| individually-tailored intervention | Experimental | participants received individually-tailored intervention Receives: Behavioral: individually-tailored intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: baseline to 6 month follow up
Secondary outcomes (1)
physical activity, dietary intake, coping strategy
Measured: baseline to 6 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 posted18 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961246
- Sponsor's protocol ID
- H11584-31742
- Other IDs
- KL2RR024130
- Acronym
- WEBABC
- Status last verified
- Sep 2013
- First submitted
- 16 Aug 2009
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Active Balance Childhood Study in Chinese-American (Web ABC Study): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00961246
- Acronym / sponsor ID
- WEBABC / H11584-31742
- Conditions
- Healthy
- Keywords
- web based intervention, individually-tailored, Chinese-American children, compared the changes in physical activity level, changes in dietary intake, changes in coping strategy used, changes in BMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Aug 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.
This study compares the feasibility and efficacy of an individually tailored, child-centered, Internet-based behavioral intervention with that of general Internet-based health information for improving health behaviors and relative weight in Chinese-American children during a 6-month period. A total of 60 children (age 10-14) and their families will be randomized to either the intervention group or control group. The intervention is based on the Social Cognitive Theory and Transtheoretical Model.
Detailed description
The proposed study will use a randomized experimental design to examine the effects of an individually tailored, Internet-based behavioral intervention program on improving health behavior (dietary intake and physical activity) and anthropometrics of Chinese-American children. A total of 60 children and their families will be recruited. The intervention will include a weekly Internet session tailored to each individual child for eight weeks and three Internet sessions for parents. Children and their parents in the control group will receive general health information on healthy eating, active lifestyles, dental care, smoking cessation, and risk taking issues via the Internet. The content of the sessions is described later. After informed consent is obtained from parents and verbal assent from the children, baseline data (T0) will be collected before assigning the children and parents to the intervention group or control group. Follow-up data for both groups will be collected at 2 months (T1), 4 months (T2) and 6 months (T3) after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general health information group | Active comparator | Behavioral: general health informationparticipants received general health information |
| individually-tailored intervention | Experimental | Behavioral: individually-tailored interventionparticipants received individually-tailored intervention |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- children between the ages of 10 and 14 years old who self-identify as Chinese or of Chinese origin
- reside in the Bay Area in the same household as at least one parent, can read and speak English, and have access to the Internet at home
- parents who self-identify as Chinese or of Chinese origin
- have children between the ages of 11 and 14
- are able to read either Chinese or English
Key exclusion criteria (1 listed)
- children with chronic health problems that include any dietary modifications or activity limitations will be excluded (e.g., diabetes, exercise-induced asthma)
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 |
|---|---|---|
| general health informationparticipants received general health information | Behavioural | general health information group |
| individually-tailored interventionparticipants received individually-tailored intervention | Behavioural | individually-tailored intervention |
Primary outcome
BMI
Time frame: baseline to 6 month follow up
1 secondary outcome
physical activity, dietary intake, coping strategy
Time frame: baseline to 6 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 25 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 general health information and individually-tailored intervention in people with Healthy, run by University of California, San Francisco 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 9 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 25 Sep 2013. 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?
BMI (time frame: baseline to 6 month follow up). 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 25 Sep 2013.