Childhood ObesityPhase 2TIMENCT01290848
A Health Promotion Campaign Targeting Caregivers of Young Children
A Phase 2 study testing Take TIME Health Campaign in people with Childhood Obesity, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
This project will evaluate the effectiveness of the Take TIME health promotion campaign. The Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target parents and caregivers of children up to 8 years of age. The study will help answer the following research questions 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Take TIME Health Campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,374 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2010to Apr 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent(s) or caregiver(s) of young children (8 years of age and younger) will be eligible for the pre- and post- intervention telephone surveys.
- Intervention activities will target parents and caregivers of young children and children 8 years of age and younger, although the events, information and policies may also influence other residents of the community.
Who cannot join
- Children and adults who are not parents or caregivers for young children 8 years of age or younger are not eligible to complete the random telephone survey.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Township of Uxbridge
Uxbridge, Ontario
About this study
Official title: Take TIME for Your Child's Health: A Health Promotion Campaign Targeting Caregivers of Young Children
This project will evaluate the effectiveness of the Take TIME health promotion campaign. The Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target parents and caregivers of children up to 8 years of age.
The study will help answer the following research questions
- Are community organizations able and willing to deliver a health-promotion campaign targeting young children?
- What impact does the Take TIME campaign have on the readiness of the community to support healthy childhoods?
- What impact does the Take TIME campaign have on awareness and achievement of healthier lifestyles for young children?
- Can health promotion initiatives be "institutionalized" within the Municipality and community organizations so that the campaign will continue beyond the study period?
- Are changes in awareness and/or behaviour related to exposure to the Take TIME campaign?
Read the detailed description
The Take TIME initiative will be developed and delivered in conjunction with the Township of Uxbridge and the Heart and Stroke Foundation of Ontario. The Durham Region Health Department, the Ministry of Health Promotion and Sport, and 35 schools and community organizations have also agreed to collaborate on project activities. The health promotion campaign will occur from October 15, 2010 until May 31, 2011. The campaign activities were developed from the input of parents and programme/care providers gathered during the planning phase of this research.
The impact of the Take TIME campaign will be evaluated in two ways. The overall readiness of the community to support healthy childhoods will be evaluated using the Community Readiness Model, which relies on a series of interviews with key individuals in leadership positions. Awareness and current behaviour among community members will be assessed through the completion of telephone surveys of randomly selected households. Each of these evaluations will be completed twice, before and after delivery of the Take TIME campaign. The pre-campaign evaluations will be completed in September 2010. The post-campaign evaluations, using the same procedures, will be completed in June 2011.
- Conditions
- Childhood Obesity
- Being tested
- Take TIME Health Campaign
- Keywords
- pediatrics, Health Promotion Campaign, Community events
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take TIME Health CampaignBehavioural
- Provision of free, family-based events, at least twice per month, that offer opportunities for physical activity and/or healthy eating in a safe, tobacco-free environment.
- Information dissemination, via project web site, media and other formats, on how to achieve a healthier lifestyle with the already hectic family schedules.
- Adoption of guidelines by community organizations and the Township of Uxbridge that will reduce tobacco exposure, increase safety and promote physical activity and healthy eating for young children.
| Study group | Role | What they receive |
|---|---|---|
| Township of Uxbridge | Experimental | The Take TIME for Your Child's Health campaign will target parents and caregivers of children up to 8 years of age. Receives: Behavioral: Take TIME Health Campaign |
| Township of Guelph/Ermosa | No intervention | For a control group the investigators have selected a community that is similar in size, household composition, population density, distance from Toronto and economic status to the Township of Uxbridge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness and current behaviour
Household Survey: Randomly selected households will be contacted by telephone to complete the survey questions. The questions address the four key themes of the Take TIME campaign: physical activity, healthy eating, and reducing exposure to injury and tobacco. For each theme, a series of questions are used to assess knowledge, awareness and family behaviour
Measured: Baseline
Awareness and current behaviour
Household Survey: Randomly selected households will be contacted by telephone to complete the survey questions. The questions address the four key themes of the Take TIME campaign: physical activity, healthy eating, and reducing exposure to injury and tobacco. For each theme, a series of questions are used to assess knowledge, awareness and family behaviour
Measured: Post-Intervention (9 months)
Secondary outcomes (1)
Readiness of the community to support healthy childhoods
A Community Readiness Score will be calculated according to the methods of Findholt for each key stakeholder interview completed. Pre- and post-campaign scores will be compared to determine changes in Community Readiness over the timeframe of the Take TIME for Your Child's Health campaign.
This second analysis will seek to obtain descriptive information on community strengths and barriers that might impact the success of the Take TIME intervention, and identify similarities and differences between the perspectives of the leader participants.
Measured: Baseline, Post-Intervention (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Township of Uxbridge
- Responsible party
- Principal investigator, Brian McCrindle, The Hospital for Sick Children
- Investigators
- Brian McCrindle, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290848
- Sponsor's protocol ID
- 1000020942
- Acronym
- TIME
- Status last verified
- Aug 2013
- First submitted
- 3 Feb 2011
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take TIME for Your Child's Health: A Health Promotion Campaign Targeting Caregivers of Young Children
- ClinicalTrials.gov ID
- NCT01290848
- Acronym / sponsor ID
- TIME / 1000020942
- Conditions
- Childhood Obesity
- Keywords
- pediatrics, Health Promotion Campaign, Community events
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,374 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Township of Uxbridge
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Feb 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.
This project will evaluate the effectiveness of the Take TIME health promotion campaign. The Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target parents and caregivers of children up to 8 years of age.
The study will help answer the following research questions
- Are community organizations able and willing to deliver a health-promotion campaign targeting young children?
- What impact does the Take TIME campaign have on the readiness of the community to support healthy childhoods?
- What impact does the Take TIME campaign have on awareness and achievement of healthier lifestyles for young children?
- Can health promotion initiatives be "institutionalized" within the Municipality and community organizations so that the campaign will continue beyond the study period?
- Are changes in awareness and/or behaviour related to exposure to the Take TIME campaign?
Detailed description
The Take TIME initiative will be developed and delivered in conjunction with the Township of Uxbridge and the Heart and Stroke Foundation of Ontario. The Durham Region Health Department, the Ministry of Health Promotion and Sport, and 35 schools and community organizations have also agreed to collaborate on project activities. The health promotion campaign will occur from October 15, 2010 until May 31, 2011. The campaign activities were developed from the input of parents and programme/care providers gathered during the planning phase of this research.
The impact of the Take TIME campaign will be evaluated in two ways. The overall readiness of the community to support healthy childhoods will be evaluated using the Community Readiness Model, which relies on a series of interviews with key individuals in leadership positions. Awareness and current behaviour among community members will be assessed through the completion of telephone surveys of randomly selected households. Each of these evaluations will be completed twice, before and after delivery of the Take TIME campaign. The pre-campaign evaluations will be completed in September 2010. The post-campaign evaluations, using the same procedures, will be completed in June 2011.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Township of Uxbridge | Experimental | Behavioral: Take TIME Health CampaignThe Take TIME for Your Child's Health campaign will target parents and caregivers of children up to 8 years of age. |
| Township of Guelph/Ermosa | No intervention | –For a control group the investigators have selected a community that is similar in size, household composition, population density, distance from Toronto and economic status to the Township of Uxbridge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parent(s) or caregiver(s) of young children (8 years of age and younger) will be eligible for the pre- and post- intervention telephone surveys.
- Intervention activities will target parents and caregivers of young children and children 8 years of age and younger, although the events, information and policies may also influence other residents of the community.
Key exclusion criteria (1 listed)
- Children and adults who are not parents or caregivers for young children 8 years of age or younger are not eligible to complete the random telephone survey.
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 |
|---|---|---|
| Take TIME Health Campaign1. Provision of free, family-based events, at least twice per month, that offer opportunities for physical activity and/or healthy eating in a safe, tobacco-free environment. 2. Information dissemination, via project web site, media and other formats, on how to achieve a healthier lifestyle with the already hectic family schedules. 3. Adoption of guidelines by community organizations and the Township of Uxbridge that will reduce tobacco exposure, increase safety and promote physical activity and healthy eating for young children. | Behavioural | Township of Uxbridge |
Primary outcome
Awareness and current behaviour
Time frame: Baseline
Household Survey: Randomly selected households will be contacted by telephone to complete the survey questions. The questions address the four key themes of the Take TIME campaign: physical activity, healthy eating, and reducing exposure to injury and tobacco. For each theme, a series of questions are used to assess knowledge, awareness and family behaviour
Awareness and current behaviour
Time frame: Post-Intervention (9 months)
Household Survey: Randomly selected households will be contacted by telephone to complete the survey questions. The questions address the four key themes of the Take TIME campaign: physical activity, healthy eating, and reducing exposure to injury and tobacco. For each theme, a series of questions are used to assess knowledge, awareness and family behaviour
1 secondary outcome
Readiness of the community to support healthy childhoods
Time frame: Baseline, Post-Intervention (9 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 27 Aug 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.
Brian McCrindle, MD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Take TIME Health Campaign in people with Childhood Obesity, run by The Hospital for Sick Children at 2 sites in Canada.
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 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Awareness and current behaviour (time frame: Baseline). The study lists 2 primary outcomes in all. 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 27 Aug 2013.