DiabetesNCT06631105
Capability Assessment for Diet and Activity (CADA) Model for Diabetes
An observational study of Diabetes, run by University of Central Florida at 1 site in United States.
Trial summary
This study investigates the capabilities related to diet, physical activity, screening, and knowledge among diabetic adults with or without a history of hospital admissions in Central Florida. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 10 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants must be 18 years of age or older and diagnosed with diabetes to take part in this research study . Participants do not need to have ever been hospitalized to take part in this study. Participants will provide informed consent online and complete the survey online at their convenience. This study is available in English and Spanish.
Who may be able to join
- Adults over the age of 18.
- Persons diagnosed with diabetes
- Have an email account with access to a reliable internet connection or smartphone
Who cannot join
- Minors , ages under 18
- Adults not diagnosed with diabetes
- Adults who are unable to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32827
Amoy C Fraser, PhD, CCRP, PMP, 4072668742, Amoy.Fraser@ucf.edu
Britney-Ann Wray, BS, CTBS, 4072668742, britney-ann.wray@ucf.edu
About this study
Official title: Capability Assessment for Diet and Activity Model Extended to Include Screening and Knowledge in Diabetic Adults
This study investigates the capabilities related to diet, physical activity, screening, and knowledge among diabetic adults with or without a history of hospital admissions in Central Florida. The hypothesis is that enhancing these capabilities, based on the Capability Approach framework, can significantly reduce hospital readmissions and improve diabetes management outcomes.
Read the detailed description
Managing diabetes effectively requires a comprehensive understanding of various capabilities, including diet, physical activity, regular screening, and diabetes-related knowledge. For diabetic adults with a history of hospital admissions, these capabilities are critical in preventing readmissions and improving overall health outcomes.
The objective of this study is to extend the investigation of feasible opportunities for managing diabetes by including measures of screening practices and knowledge alongside diet and physical activity. By employing the Capability Approach, this research aims to provide a comprehensive assessment of how these capabilities interact with individual and environmental factors to affect diabetes management. This approach will enrich existing knowledge by highlighting the interplay between diet, activity, screening, and knowledge, and how these factors collectively impact health outcomes. It will also inform targeted interventions that address both personal and environmental determinants of diabetes management, contributing to more effective public health strategies.
The study uses a survey instrument to collect data from diabetic adults who have experienced hospital admissions in Central Florida and those who don't. The data will be analyzed using Structural Equation Modeling (SEM) to explore the relationships and potential causal pathways between the capabilities assessed (diet, activity, screening, knowledge) and health outcomes. This approach, grounded in the Capability Approach framework, will help identify how each capability contributes to the management of diabetes and highlight areas for targeted interventions.
This study is available in English and Spanish.
- Conditions
- Diabetes
- Keywords
- Diabetes, Hospital Admission, Hospital
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of relationships between capabilities and health outcomes using the Structural Equation Modeling (SEM) based on the Capability Approach
The research employs a survey instrument with Likert-scale and open-ended questions, targeting diabetic adults with or without previous hospital admissions in Central Florida. Structural Equation Modeling (SEM) based on the Capability Approach will be used to analyze the data, allowing for the examination of relationships between capabilities (diet, activity, screening, knowledge) and health outcomes. The SEM will help identify the direct and indirect effects of these capabilities on diabetes management, providing insights into potential intervention points for improving health outcomes in this population.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start10 Jan 2025
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- AdventHealth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631105
- Sponsor's protocol ID
- STUDY00006976
- Status last verified
- Mar 2025
- First submitted
- 4 Oct 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capability Assessment for Diet and Activity Model Extended to Include Screening and Knowledge in Diabetic Adults
- ClinicalTrials.gov ID
- NCT06631105
- Acronym / sponsor ID
- STUDY00006976
- Conditions
- Diabetes
- Keywords
- Diabetes, Hospital Admission, Hospital
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- AdventHealth
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 8 Oct 2024 (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.
This study investigates the capabilities related to diet, physical activity, screening, and knowledge among diabetic adults with or without a history of hospital admissions in Central Florida. The hypothesis is that enhancing these capabilities, based on the Capability Approach framework, can significantly reduce hospital readmissions and improve diabetes management outcomes.
Detailed description
Managing diabetes effectively requires a comprehensive understanding of various capabilities, including diet, physical activity, regular screening, and diabetes-related knowledge. For diabetic adults with a history of hospital admissions, these capabilities are critical in preventing readmissions and improving overall health outcomes.
The objective of this study is to extend the investigation of feasible opportunities for managing diabetes by including measures of screening practices and knowledge alongside diet and physical activity. By employing the Capability Approach, this research aims to provide a comprehensive assessment of how these capabilities interact with individual and environmental factors to affect diabetes management. This approach will enrich existing knowledge by highlighting the interplay between diet, activity, screening, and knowledge, and how these factors collectively impact health outcomes. It will also inform targeted interventions that address both personal and environmental determinants of diabetes management, contributing to more effective public health strategies.
The study uses a survey instrument to collect data from diabetic adults who have experienced hospital admissions in Central Florida and those who don't. The data will be analyzed using Structural Equation Modeling (SEM) to explore the relationships and potential causal pathways between the capabilities assessed (diet, activity, screening, knowledge) and health outcomes. This approach, grounded in the Capability Approach framework, will help identify how each capability contributes to the management of diabetes and highlight areas for targeted interventions.
This study is available in English and Spanish.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants must be 18 years of age or older and diagnosed with diabetes to take part in this research study . Participants do not need to have ever been hospitalized to take part in this study. Participants will provide informed consent online and complete the survey online at their convenience. This study is available in English and Spanish.
Key inclusion criteria (3 listed)
- Adults over the age of 18.
- Persons diagnosed with diabetes
- Have an email account with access to a reliable internet connection or smartphone
Key exclusion criteria (3 listed)
- Minors , ages under 18
- Adults not diagnosed with diabetes
- Adults who are unable to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The assessment of relationships between capabilities and health outcomes using the Structural Equation Modeling (SEM) based on the Capability Approach
Time frame: 1 year
The research employs a survey instrument with Likert-scale and open-ended questions, targeting diabetic adults with or without previous hospital admissions in Central Florida. Structural Equation Modeling (SEM) based on the Capability Approach will be used to analyze the data, allowing for the examination of relationships between capabilities (diet, activity, screening, knowledge) and health outcomes. The SEM will help identify the direct and indirect effects of these capabilities on diabetes management, providing insights into potential intervention points for improving health outcomes in this population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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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.
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, run by University of Central Florida 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amoy Fraser, PhD, CCRP, PMP (4072668742, Amoy.Fraser@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of relationships between capabilities and health outcomes using the Structural Equation Modeling (SEM) based on the Capability Approach (time frame: 1 year). 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 21 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.