Type 2 Diabetes MellitusNCT00739336
Diabetes Prevention and Control in the Workplace: A Pilot Study
A study of Type 2 Diabetes Mellitus, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult employees of Onondaga County
Who cannot join
- Not an employee of Onondaga County
- Less than age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Diabetes Prevention and Control
- Keywords
- diabetes mellitus, obesity, prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention and ControlBehavioural
The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings.
| Study group | Role | What they receive |
|---|---|---|
| A, 1 | Experimental | Intervention: Immediate 3 month program Receives: Behavioral: Diabetes Prevention and Control |
| A, 2 | No intervention | Wait-List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Weight loss in kg
Measured: 3 months
Secondary outcomes (5)
Fasting Glucose Level
Fasting glucose (mg/dL)
Measured: Baseline
Fasting Lipid Profile
LDL-cholesterol (mg/dL)
Measured: Baseline
Hemoglobin A1c
hemoglobin A1c (%)
Measured: baseline
Waist Circumference
Measured: baseline, 3, 6, 12 months
Questionnaires
Measured: baseline, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- County of Onondaga, NYS, NYS Department of Health
- Responsible party
- Principal investigator, Ruth Weinstock, State University of New York - Upstate Medical University
- Investigators
- Ruth S Weinstock, MD, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739336
- Sponsor's protocol ID
- IRB#5657
- Other IDs
- NYSDOH Contract# C021750, Onondaga Cty,NY Contract#39407
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2008
- Last updated
- 5 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Barham K, West S, Trief P, Morrow C, Wade M, Weinstock RS. Diabetes prevention and control in the workplace: a pilot project for county employees. J Public Health Manag Pract. 2011 May-Jun;17(3):233-41. doi: 10.1097/PHH.0b013e3181fd4cf6.
PubMed 21464685
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention and Control in the Workplace: A Pilot Study
- ClinicalTrials.gov ID
- NCT00739336
- Acronym / sponsor ID
- IRB#5657
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes mellitus, obesity, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- County of Onondaga, NYS, NYS Department of Health
- Study start
- Jul 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1 | Experimental | Behavioral: Diabetes Prevention and ControlIntervention: Immediate 3 month program |
| A, 2 | No intervention | –Wait-List Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult employees of Onondaga County
Key exclusion criteria (2 listed)
- Not an employee of Onondaga County
- Less than age 18
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 |
|---|---|---|
| Diabetes Prevention and ControlThe program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings. | Behavioural | A, 1 |
Primary outcome
Body Weight
Time frame: 3 months
Weight loss in kg
5 secondary outcomes
Fasting Glucose Level
Time frame: Baseline
Fasting Lipid Profile
Time frame: Baseline
Hemoglobin A1c
Time frame: baseline
Waist Circumference
Time frame: baseline, 3, 6, 12 months
Questionnaires
Time frame: baseline, 3, 6, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21464685Barham K, West S, Trief P, Morrow C, Wade M, Weinstock RS. Diabetes prevention and control in the workplace: a pilot project for county employees. J Public Health Manag Pract. 2011 May-Jun;17(3):233-41. doi: 10.1097/PHH.0b013e3181fd4cf6.
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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.
Ruth S Weinstock, MD, PhD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 2 Diabetes Mellitus, run by State University of New York - Upstate Medical 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 2 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 5 Oct 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Weight (time frame: 3 months). 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 NCT00739336, which also lists 1 linked publication.
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 5 Oct 2016.