Diabetes Mellitus, Type 2DWDNCT04080960
Dining With Diabetes in Pennsylvania
An observational study of Diabetes Mellitus, Type 2, run by Penn State University at 1 site in United States.
Trial summary
Penn State Extension's Dining with Diabetes program is an evidence-based community education program for people with or at risk for type 2 diabetes. The program teaches participants how to prevent or manage their disease by providing practical knowledge and strategies to make the necessary lifestyle changes that will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle modification education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 30 Apr 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults residents of Pennsylvania
Who may be able to join
- Individuals with type 2 diabetes individuals with pre-diabetes individuals at risk of developing type 2 diabetes healthy family members/caretakers healthy volunteers
Who cannot join
- under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Penn State Extension's Dining with Diabetes program is an evidence-based community education program for people with or at risk for type 2 diabetes. The program teaches participants how to prevent or manage their disease by providing practical knowledge and strategies to make the necessary lifestyle changes that will lead to healthier living and reduction in the risk of complications. The overall goals and objectives of the program are as follows:
Increasing knowledge of healthy food choices for families with or at risk for diabetes Promoting behavior changes by offering demonstrations and tasting of healthy food.
Read more
Increasing knowledge of essential medical tests associated with diabetes management.
Promoting physical activity as a component of diabetes control. Encouraging self-management and self-efficacy skill. Connecting participants to their healthcare providers for long-term follow-up. The program is designed to meet 4 consecutive weeks and then a 3 month follow-up. Participants A1c and blood pressure are taking at the first and follow-up classes. Classes consist of a nutrition lesson, physical activity, cooking demonstration and food tasting.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lifestyle modification education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modification educationBehavioural
Lifestyle modification education and goal setting
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1C
participants can choose to have their hemoglobin A1C taken at the first and follow-up class, 3 months later
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 May 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080960
- Sponsor's protocol ID
- PRAMS00036501
- Other IDs
- 208113
- Acronym
- DWD
- Status last verified
- Jun 2021
- First submitted
- 4 Sep 2019
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griffie D, James L, Goetz S, Balotti B, Shr YH, Corbin M, Kelsey TW. Outcomes and Economic Benefits of Penn State Extension's Dining With Diabetes Program. Prev Chronic Dis. 2018 May 3;15:E50. doi: 10.5888/pcd15.170407.
PubMed 29729134
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dining With Diabetes in Pennsylvania
- ClinicalTrials.gov ID
- NCT04080960
- Acronym / sponsor ID
- DWD / PRAMS00036501
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
Penn State Extension's Dining with Diabetes program is an evidence-based community education program for people with or at risk for type 2 diabetes. The program teaches participants how to prevent or manage their disease by providing practical knowledge and strategies to make the necessary lifestyle changes that will lead to healthier living and reduction in the risk of complications. The overall goals and objectives of the program are as follows:
Increasing knowledge of healthy food choices for families with or at risk for diabetes Promoting behavior changes by offering demonstrations and tasting of healthy food.
Increasing knowledge of essential medical tests associated with diabetes management.
Promoting physical activity as a component of diabetes control. Encouraging self-management and self-efficacy skill. Connecting participants to their healthcare providers for long-term follow-up. The program is designed to meet 4 consecutive weeks and then a 3 month follow-up. Participants A1c and blood pressure are taking at the first and follow-up classes. Classes consist of a nutrition lesson, physical activity, cooking demonstration and food tasting.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults residents of Pennsylvania
Key inclusion criteria (1 listed)
- Individuals with type 2 diabetes individuals with pre-diabetes individuals at risk of developing type 2 diabetes healthy family members/caretakers healthy volunteers
Key exclusion criteria (1 listed)
- under 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 |
|---|---|---|
| Lifestyle modification educationLifestyle modification education and goal setting | Behavioural | – |
Primary outcome
hemoglobin A1C
Time frame: 3 months
participants can choose to have their hemoglobin A1C taken at the first and follow-up class, 3 months later
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 4 Jun 2021.
- Results publication: PubMed 29729134Griffie D, James L, Goetz S, Balotti B, Shr YH, Corbin M, Kelsey TW. Outcomes and Economic Benefits of Penn State Extension's Dining With Diabetes Program. Prev Chronic Dis. 2018 May 3;15:E50. doi: 10.5888/pcd15.170407.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Penn 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 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 4 Jun 2021. 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?
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?
hemoglobin A1C (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 NCT04080960, 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 4 Jun 2021.