Type 2 DiabetesDvtENERGYNCT00542113
Diabetes Virtual Trek: Obesity and Diabetes Prevention Through Science Enrichment
A study testing DvtProgram ENERGY and DvtProgramENERGY in people with Type 2 Diabetes and Obesity, run by Colorado State University at 2 sites in United States.
Trial summary
The purpose of this study was to evaluate the effectiveness of a school-to-home education program for it's ability to increase knowledge about, and ability to prevent type two diabetes in children and parents. 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?
- DvtProgram ENERGY and DvtProgramENERGY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,703 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2001to Jun 2008
- 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 children in grade 2-6 in intervention or comparison classes/schools
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montezuma-Cortez School District
Cortez, Colorado, 81321
Putnam, Tavelli, Bennett and Dunn Elementary Schools
Fort Collins, Colorado, 80524
About this study
Official title: Diabetes Virtual Trek Prevention: Obesity and Diabetes Prevention Through Science Enrichment
The purpose of this study was to evaluate the effectiveness of a school-to-home education program for it's ability to increase knowledge about, and ability to prevent type two diabetes in children and parents.
Read the detailed description
The study involved pre and post testing of parent's knowledge and behaviors relating to the prevention of type two diabetes, before and after a school based intervention designed to encourage school to home communication. Parents/Guardians and children, grades 2-6, from schools with high Hispanic enrollment during the 2001-2005 school year were used for both comparison and intervention groups.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- DvtProgram ENERGY, DvtProgramENERGY
- Keywords
- Parental, Parents, Prevention, Energy balance, Glucose regulation, Healthy lifestyles, Healthy families, 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.
DvtProgram ENERGYBehavioural
11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
DvtProgram ENERGYBehavioural
6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children
DvtProgramENERGYBehavioural
Children participating in Program ENERGY but no newsletters or family challenges sent home to parents
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Parents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 1 Receives: Behavioral: DvtProgram ENERGY |
| 2 | Experimental | Parents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 2 Receives: Behavioral: DvtProgram ENERGY |
| 3 | Sham comparator | Parents of elementary school children in grades 2-6 participating in Program ENERGY matched to the intervention groups Receives: Behavioral: DvtProgramENERGY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes knowledge and prevention of parents of elementary school children
Measured: one-three school year(s)
Secondary outcomes (1)
Self-reported parental 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 startSep 2001
- Primary completionJun 2008
- Study completionJun 2008
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
- 1,703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Poudre School District, Fort Collins, CO, Montezuma-Cortez School District, Cortez, CO
- Responsible party
- Sponsor
- Investigators
- L. Arthur Campfield, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542113
- Sponsor's protocol ID
- H 00-301H R25 015646
- Other IDs
- R25RR015646, R25RR020469
- Acronym
- DvtENERGY
- 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
- Diabetes Virtual Trek Prevention: Obesity and Diabetes Prevention Through Science Enrichment
- ClinicalTrials.gov ID
- NCT00542113
- Acronym / sponsor ID
- DvtENERGY / H 00-301H R25 015646
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Parental, Parents, Prevention, Energy balance, Glucose regulation, Healthy lifestyles, Healthy families, Active living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,703 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Poudre School District, Fort Collins, CO, Montezuma-Cortez School District, Cortez, CO
- Study start
- Sep 2001
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (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.
The purpose of this study was to evaluate the effectiveness of a school-to-home education program for it's ability to increase knowledge about, and ability to prevent type two diabetes in children and parents.
Detailed description
The study involved pre and post testing of parent's knowledge and behaviors relating to the prevention of type two diabetes, before and after a school based intervention designed to encourage school to home communication. Parents/Guardians and children, grades 2-6, from schools with high Hispanic enrollment during the 2001-2005 school year were used for both comparison and intervention groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: DvtProgram ENERGYParents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 1 |
| 2 | Experimental | Behavioral: DvtProgram ENERGYParents of elementary school children in grades 2-6 participating in Program ENERGY -Intervention 2 |
| 3 | Sham comparator | Behavioral: DvtProgramENERGYParents of elementary school children in grades 2-6 participating in Program ENERGY matched to the intervention groups |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Elementary school children in grade 2-6 in 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 |
|---|---|---|
| DvtProgram ENERGY11 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children | Behavioural | 2 |
| DvtProgram ENERGY6 - weekly or biweekly newsletters about diabetes and its prevention and family challenges sent home with children | Behavioural | 1 |
| DvtProgramENERGYChildren participating in Program ENERGY but no newsletters or family challenges sent home to parents | Behavioural | 3 |
Primary outcome
Diabetes knowledge and prevention of parents of elementary school children
Time frame: one-three school year(s)
1 secondary outcome
Self-reported parental 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DvtProgram ENERGY and DvtProgramENERGY in people with Type 2 Diabetes and Obesity, run by Colorado State University at 2 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 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 2 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. 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 of parents of 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.