Type 2 DiabetesDKENERGYNCT00541879
Obesity and Diabetes Prevention Through Science Enrichment
A study testing Program ENERGY and comparison in people with Type 2 Diabetes and Obesity, run by Colorado State University at 1 site in United States.
Trial summary
Type 2 diabetes and obesity in children continue to increase at alarming rates with devastating results. However, both these metabolic diseases are largely preventable through adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy balance and some simple aspects of glucose… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Program ENERGY and comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,909 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Sep 2011
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Elementary school child in selected intervention or comparison classes/schools
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Putnam, Tavelli, Bennett and Dunn Elementary Schools
Fort Collins, Colorado, 80524
About this study
Official title: Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment
Type 2 diabetes and obesity in children continue to increase at alarming rates with devastating results. However, both these metabolic diseases are largely preventable through adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy balance and some simple aspects of glucose regulation. Can elementary school children be taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? Children need to learn this essential knowledge and practice these important health behavior skills. Elementary school may be an ideal place to master this subject that is a direct and logical extension of current health curricula including nutrition and physical activity blended with science and math.
Read the detailed description
Biomedical scientists lead a classroom series of interactive, inquiry-based science and health explorations directed at type 2 diabetes, obesity and their prevention in three elementary schools serving children at high risk for type 2 diabetes. Diabetes knowledge was measured in children and parents at the beginning, end and 9 months after the end of the intervention using validated questionnaires.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Program ENERGY, comparison
- Keywords
- Childhood, Prevention, Energy balance, Glucose regulation, Healthy lifestyle, Healthy eating, Active living
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program ENERGYBehavioural
Weekly or biweekly classroom and gym based science enrichment focused on how the body works including blood glucose regulation, healthy eating and physical activity, diabetes abd how it can be prevented
comparisonOther
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Elementary school children -grades 2-6 participating in Program ENERGY Receives: Behavioral: Program ENERGY |
| II | Sham comparator | Elementary school children in grades 2-6 matched to the intervention classes not receiving any intervention Receives: Other: comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes knowledge and prevention behaviors in elementary school children
Measured: one-three school year(s)
Secondary outcomes (1)
Parental diabetes knowledge, self-reported physical activity
Measured: one -three school year(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startAug 2001
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), Poudre School District, Fort Collins, CO
- Responsible party
- Sponsor
- Investigators
- L. Arthur Campfield, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541879
- Sponsor's protocol ID
- H 04-257 RR25 RR 020469
- Other IDs
- R 25 RR 020469, R 25 RR 015646
- Acronym
- DKENERGY
- Status last verified
- Nov 2014
- First submitted
- 9 Oct 2007
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Knowledge: Obesity and Diabetes Prevention Through Science Enrichment
- ClinicalTrials.gov ID
- NCT00541879
- Acronym / sponsor ID
- DKENERGY / H 04-257 RR25 RR 020469
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Childhood, Prevention, Energy balance, Glucose regulation, Healthy lifestyle, Healthy eating, Active living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,909 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR), Poudre School District, Fort Collins, CO
- Study start
- Aug 2001
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Oct 2007 (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.
Type 2 diabetes and obesity in children continue to increase at alarming rates with devastating results. However, both these metabolic diseases are largely preventable through adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy balance and some simple aspects of glucose regulation. Can elementary school children be taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? Children need to learn this essential knowledge and practice these important health behavior skills. Elementary school may be an ideal place to master this subject that is a direct and logical extension of current health curricula including nutrition and physical activity blended with science and math.
Detailed description
Biomedical scientists lead a classroom series of interactive, inquiry-based science and health explorations directed at type 2 diabetes, obesity and their prevention in three elementary schools serving children at high risk for type 2 diabetes. Diabetes knowledge was measured in children and parents at the beginning, end and 9 months after the end of the intervention using validated questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: Program ENERGYElementary school children -grades 2-6 participating in Program ENERGY |
| II | Sham comparator | Other: comparisonElementary school children in grades 2-6 matched to the intervention classes not receiving any intervention |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Elementary school child in selected intervention or comparison classes/schools
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Program ENERGYWeekly or biweekly classroom and gym based science enrichment focused on how the body works including blood glucose regulation, healthy eating and physical activity, diabetes abd how it can be prevented | Behavioural | I |
| comparison | Other | II |
Primary outcome
Diabetes knowledge and prevention behaviors in elementary school children
Time frame: one-three school year(s)
1 secondary outcome
Parental diabetes knowledge, self-reported physical activity
Time frame: one -three school year(s)
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 7 Nov 2014.
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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.
L. Arthur Campfield, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program ENERGY and comparison in people with Type 2 Diabetes and Obesity, run by Colorado State University 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 0 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 7 Nov 2014. 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. 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?
Diabetes knowledge and prevention behaviors in elementary school children (time frame: one-three school year(s)). 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 7 Nov 2014.