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Dining With Diabetes in Pennsylvania (DWD)

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ClinicalTrials.gov Identifier: NCT04080960
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Debra Griffie, Penn State University

Tracking Information
First Submitted Date September 4, 2019
First Posted Date September 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date May 1, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dining With Diabetes in Pennsylvania
Official Title Dining With Diabetes in Pennsylvania
Brief 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 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults residents of Pennsylvania
Condition Diabetes Mellitus, Type 2
Intervention Behavioral: Lifestyle modification education
Lifestyle modification education and goal setting
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 5, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Individuals with type 2 diabetes individuals with pre-diabetes individuals at risk of developing type 2 diabetes healthy family members/caretakers healthy volunteers

Exclusion Criteria:

  • under age 18
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Debra A Griffie, EdD 610-489-4315 dab210@psu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04080960
Other Study ID Numbers PRAMS00036501
208113 ( Other Grant/Funding Number: NNLM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Debra Griffie, Penn State University
Study Sponsor Penn State University
Collaborators Not Provided
Investigators Not Provided
PRS Account Penn State University
Verification Date September 2019