OverweightEarly Phase 1SWITCHNCT00685555
Healthy Futures Project: A Community Based Obesity Prevention Program
A Early Phase 1 study testing Switch active lifestyles brought to you by MediaWise and Switch active lifestyles from MediaWise in people with Overweight and Obesity, run by National Institute on Media and the Family at 1 site in United States.
Trial summary
The purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Switch active lifestyles brought to you by MediaWise and Switch active lifestyles from MediaWise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2006
- Phase
- Early Phase 1
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children in 3-5 grades who provide parental consent and child assent will be eligible to participate in the project.
Who cannot join
- Participants who meet the following exclusion criteria will not be considered for participation.
- Do not provide consent
- unable or unwilling to adhere to project procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Media and the Family
Minneapolis, Minnesota, 55454
About this study
Official title: SWITCH: Rationale, Design, and Implementation of a Community, School, and Family-based Intervention to Modify Behaviors Related to Childhood Obesity
The purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management.
The problem of obesity is at epidemic proportions and has become the most important public health problem confronting the United States today. Of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. Childhood obesity is a precursor of adult obesity.
Read the detailed description
The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity. Through community education, family-based strategies and partnerships with schools, 3rd, 4th and 5th graders are encouraged to: Switch what you Do™ Switch what you View™ Switch what you Chew™.
- Conditions
- Overweight, Obesity
- Being tested
- Switch active lifestyles brought to you by MediaWise, Switch active lifestyles from MediaWise
- Keywords
- Screen time, Fruits and Vegetable Consumption, Physical Activity, Obesity, Overweight
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch active lifestyles brought to you by MediaWiseBehavioural
Also called Iowa State University, Michigan State University, National Institute on Media and the Family
The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity.
Switch active lifestyles from MediaWiseBehavioural
Also called Switch, Switch program, The Switch program
1300 students (male and female) were recruited through two separate school districts in Lakeville, Minnesota and Cedar Rapids, Iowa. Informed consents went to all students who chose to participate. Demonstration and Control school were randomly selected. Baseline data was collected regarding physical activity, screen time, and nutrition, standard body measurements, and baseline data, and salivary cortisol levels were taken. Parent and teacher surveys were also conducted. After baseline selected demonstration sites and students were provided with information focused on improving healthy behaviors while the control sites served as matched comparison groups.
What is being measured
The primary outcome is the main question the study is designed to answer.
Our outcome measure was reduction of screen time
Measured: 4 waves of data
Secondary outcomes (1)
Our secondary outcome measure increase in fruit and vegetable consumption.
Measured: T1-PRE Intervention toT2 Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startOct 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Media and the Family
- Sponsor type
- University, hospital or other
- Collaborators
- Fairview Health Services, Medica, Healthy and Active America Foundation,, Cargill, Spunk Design Machine, Iowa State University, Michigan State University, University of Minnesota
- Investigators
- Dave Walsh, Ph.D., Principal investigator, National Institute on Media and the Family
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685555
- Sponsor's protocol ID
- NIMF-1300-05
- Acronym
- SWITCH
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Eisenmann JC, Laurson KR, Wickel EE, Gentile D, Walsh D. Utility of pedometer step recommendations for predicting overweight in children. Int J Obes (Lond). 2007 Jul;31(7):1179-82. doi: 10.1038/sj.ijo.0803553. Epub 2007 Jan 30.
PubMed 17264846Eisenmann JC, Gentile DA, Welk GJ, Callahan R, Strickland S, Walsh M, Walsh DA. SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity. BMC Public Health. 2008 Jun 29;8:223. doi: 10.1186/1471-2458-8-223.
PubMed 18588706
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWITCH: Rationale, Design, and Implementation of a Community, School, and Family-based Intervention to Modify Behaviors Related to Childhood Obesity
- ClinicalTrials.gov ID
- NCT00685555
- Acronym / sponsor ID
- SWITCH / NIMF-1300-05
- Conditions
- Overweight, Obesity
- Keywords
- Screen time, Fruits and Vegetable Consumption, Physical Activity, Obesity, Overweight
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- National Institute on Media and the FamilyUniversity, hospital or other
- Collaborators
- Fairview Health Services, Medica, Healthy and Active America Foundation,, Cargill, Spunk Design Machine, Iowa State University, Michigan State University, University of Minnesota
- Study start
- Oct 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 28 May 2008 (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 purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management.
The problem of obesity is at epidemic proportions and has become the most important public health problem confronting the United States today. Of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. Childhood obesity is a precursor of adult obesity.
Detailed description
The Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity. Through community education, family-based strategies and partnerships with schools, 3rd, 4th and 5th graders are encouraged to: Switch what you Do™ Switch what you View™ Switch what you Chew™.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children in 3-5 grades who provide parental consent and child assent will be eligible to participate in the project.
Key exclusion criteria (3 listed)
- Participants who meet the following exclusion criteria will not be considered for participation.
- Do not provide consent
- unable or unwilling to adhere to project procedures
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 |
|---|---|---|
| Switch active lifestyles brought to you by MediaWiseAlso: Iowa State University, Michigan State University, National Institute on Media and the FamilyThe Switch™ Program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity. | Behavioural | – |
| Switch active lifestyles from MediaWiseAlso: Switch, Switch program, The Switch program1300 students (male and female) were recruited through two separate school districts in Lakeville, Minnesota and Cedar Rapids, Iowa. Informed consents went to all students who chose to participate. Demonstration and Control school were randomly selected. Baseline data was collected regarding physical activity, screen time, and nutrition, standard body measurements, and baseline data, and salivary cortisol levels were taken. Parent and teacher surveys were also conducted. After baseline selected demonstration sites and students were provided with information focused on improving healthy behaviors while the control sites served as matched comparison groups. | Behavioural | – |
Primary outcome
Our outcome measure was reduction of screen time
Time frame: 4 waves of data
1 secondary outcome
Our secondary outcome measure increase in fruit and vegetable consumption.
Time frame: T1-PRE Intervention toT2 Post Intervention
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 23 Jun 2011.
- Results publication: PubMed 17264846Eisenmann JC, Laurson KR, Wickel EE, Gentile D, Walsh D. Utility of pedometer step recommendations for predicting overweight in children. Int J Obes (Lond). 2007 Jul;31(7):1179-82. doi: 10.1038/sj.ijo.0803553. Epub 2007 Jan 30.
- Derived from this study: PubMed 18588706Eisenmann JC, Gentile DA, Welk GJ, Callahan R, Strickland S, Walsh M, Walsh DA. SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity. BMC Public Health. 2008 Jun 29;8:223. doi: 10.1186/1471-2458-8-223.
- National Institute on Media and the FamilyLink provided by the sponsor.
- Co-Investigator Douglas Gentile Ph.D.Link provided by the sponsor.
Related trials for Overweight
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
RecruitingPhase 2
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Healthy Volunteers, Overweight
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.
Dave Walsh, Ph.D. principal investigator
National Institute on Media and the Family
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Switch active lifestyles brought to you by MediaWise and Switch active lifestyles from MediaWise in people with Overweight and Obesity, run by National Institute on Media and the Family 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 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 23 Jun 2011. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Our outcome measure was reduction of screen time (time frame: 4 waves of data). 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 NCT00685555, which also lists 2 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 23 Jun 2011; AzTrials last refreshed its copy on 1 Nov 2026.