DiabetesNCT04427982
Dance and Diabetes/Prediabetes Self-Management
A study testing dance and diabetes education in people with Diabetes and Pre Diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The Dance for Diabetes program was designed as a community service project for the North Carolina Albert Schweitzer Fellowship. The purpose of this research is to evaluate the effectiveness of the project and its impact on participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Pre Diabetes
- What is being tested?
- dance and diabetes education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 3 May 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults proficient in English with diabetes or prediabetes
- subjects who have an established healthcare provider
Who cannot join
- known cardiovascular disease (acute coronary syndrome, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, and peripheral arterial disease) for the last 6 months
- unwilling or unable to partake in light to moderate level of dance physical activity for 1 hour because of physical impairment (e.g. wheelchair, amputation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Dance as an Intervention to Improve Diabetes and Prediabetes Self-Management
The Dance for Diabetes program was designed as a community service project for the North Carolina Albert Schweitzer Fellowship. The purpose of this research is to evaluate the effectiveness of the project and its impact on participants. This study will assess whether a group dance workshop along with diabetes education can help people with diabetes and prediabetes.
Read the detailed description
This is a pilot study that will be testing whether or not a group dance workshop is useful and effective. If it is, the study team will refine the workshop model and do additional dance classes in the future. This research study will involve attending a dance workshop once a week for 2 months using an online, video-conferencing computer application. Participants will also receive information about exercise and how to manage their diabetes. Participants will receive a phone call every week during the 2 months to assess their experience. Study participants will also be asked to complete surveys at the beginning and end of the 2-month session, as well as 1 month and 2 months after the classes end.
- Conditions
- Diabetes, Pre Diabetes
- Being tested
- dance, diabetes education
- Keywords
- dance, reduce blood sugar, prevention
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danceBehavioural
Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.
diabetes educationBehavioural
The dance classes will be followed by a brief diabetes education and discussion session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | All participants will attend a 2-month weekly light-to-moderate intensity dance workshop followed by a brief diabetes education and discussion session. Receives: Behavioral: dance; Behavioral: diabetes education |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation
Percentage of subjects who confirm that they are physically active in questionnaire
Measured: baseline
NHANES 2019-2020 PAQ--Days Active
Average number of days subjects report being active
Measured: baseline
NHANES 2019-2020 PAQ--minutes active
Average number of minutes (10-60) per day that participants engage in activity
Measured: baseline
NHANES 2019-2020 PAQ--Activity Confirmation
Percentage of subjects who confirm that they are physically active in questionnaire
Measured: 4 weeks post intervention completion
NHANES 2019-2020 PAQ--Days Active
Average number of days subjects report being active
Measured: 4 weeks post intervention completion
NHANES 2019-2020 PAQ--minutes active
Average number of minutes (10-60) per day that participants engage in activity
Measured: 4 weeks post intervention completion
NHANES 2019-2020 PAQ--Activity Confirmation
Percentage of subjects who confirm that they are physically active in questionnaire
Measured: 8 weeks post baseline
NHANES 2019-2020 PAQ--Days Active
Average number of days subjects report being active
Measured: 8 weeks post baseline
NHANES 2019-2020 PAQ--minutes active
Average number of minutes (10-60) per day that participants engage in activity
Measured: 8 weeks post baseline
NHANES 2019-2020 PAQ--Activity Confirmation
Percentage of subjects who confirm that they are physically active in questionnaire
Measured: 8 weeks post intervention completion
NHANES 2019-2020 PAQ--Days Active
Average number of days subjects report being active
Measured: 8 weeks post intervention completion
NHANES 2019-2020 PAQ--minutes active
Average number of minutes (10-60) per day that participants engage in activity
Measured: 8 weeks post intervention completion
Diabetes Empowerment Scale (DES) score
Score ranges from 1 to 5, with 1 denoting a worse outcome.
Measured: baseline
DES Score
This questionnaire is given to determine if there were any changes in participants' activity level 4 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
Measured: 4 weeks post intervention completion
DES score
This questionnaire is given 8 weeks post baseline in order to determine any improvements made during the intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
Measured: 8 weeks post baseline
DES Score
This questionnaire is given to determine if there were any changes in participants' activity level 8 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
Measured: 8 weeks post intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start3 Sep 2020
- Primary completion3 May 2021
- Study completion3 May 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the dance and education interventions.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julienne Kirk, PharmD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427982
- Sponsor's protocol ID
- IRB00065214
- Status last verified
- Oct 2021
- First submitted
- 8 Jun 2020
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be available after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance as an Intervention to Improve Diabetes and Prediabetes Self-Management
- ClinicalTrials.gov ID
- NCT04427982
- Acronym / sponsor ID
- IRB00065214
- Conditions
- Diabetes, Pre Diabetes
- Keywords
- dance, reduce blood sugar, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 11 Jun 2020 (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.
The Dance for Diabetes program was designed as a community service project for the North Carolina Albert Schweitzer Fellowship. The purpose of this research is to evaluate the effectiveness of the project and its impact on participants. This study will assess whether a group dance workshop along with diabetes education can help people with diabetes and prediabetes.
Detailed description
This is a pilot study that will be testing whether or not a group dance workshop is useful and effective. If it is, the study team will refine the workshop model and do additional dance classes in the future. This research study will involve attending a dance workshop once a week for 2 months using an online, video-conferencing computer application. Participants will also receive information about exercise and how to manage their diabetes. Participants will receive a phone call every week during the 2 months to assess their experience. Study participants will also be asked to complete surveys at the beginning and end of the 2-month session, as well as 1 month and 2 months after the classes end.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the dance and education interventions.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: dance, Behavioral: diabetes educationAll participants will attend a 2-month weekly light-to-moderate intensity dance workshop followed by a brief diabetes education and discussion session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults proficient in English with diabetes or prediabetes
- subjects who have an established healthcare provider
Key exclusion criteria (2 listed)
- known cardiovascular disease (acute coronary syndrome, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, and peripheral arterial disease) for the last 6 months
- unwilling or unable to partake in light to moderate level of dance physical activity for 1 hour because of physical impairment (e.g. wheelchair, amputation)
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 |
|---|---|---|
| danceParticipants will attend a 2-month weekly light-to-moderate intensity dance workshop. | Behavioural | Experimental Group |
| diabetes educationThe dance classes will be followed by a brief diabetes education and discussion session. | Behavioural | Experimental Group |
Primary outcome
National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation
Time frame: baseline
Percentage of subjects who confirm that they are physically active in questionnaire
NHANES 2019-2020 PAQ--Days Active
Time frame: baseline
Average number of days subjects report being active
NHANES 2019-2020 PAQ--minutes active
Time frame: baseline
Average number of minutes (10-60) per day that participants engage in activity
NHANES 2019-2020 PAQ--Activity Confirmation
Time frame: 4 weeks post intervention completion
Percentage of subjects who confirm that they are physically active in questionnaire
NHANES 2019-2020 PAQ--Days Active
Time frame: 4 weeks post intervention completion
Average number of days subjects report being active
NHANES 2019-2020 PAQ--minutes active
Time frame: 4 weeks post intervention completion
Average number of minutes (10-60) per day that participants engage in activity
NHANES 2019-2020 PAQ--Activity Confirmation
Time frame: 8 weeks post baseline
Percentage of subjects who confirm that they are physically active in questionnaire
NHANES 2019-2020 PAQ--Days Active
Time frame: 8 weeks post baseline
Average number of days subjects report being active
NHANES 2019-2020 PAQ--minutes active
Time frame: 8 weeks post baseline
Average number of minutes (10-60) per day that participants engage in activity
NHANES 2019-2020 PAQ--Activity Confirmation
Time frame: 8 weeks post intervention completion
Percentage of subjects who confirm that they are physically active in questionnaire
NHANES 2019-2020 PAQ--Days Active
Time frame: 8 weeks post intervention completion
Average number of days subjects report being active
NHANES 2019-2020 PAQ--minutes active
Time frame: 8 weeks post intervention completion
Average number of minutes (10-60) per day that participants engage in activity
Diabetes Empowerment Scale (DES) score
Time frame: baseline
Score ranges from 1 to 5, with 1 denoting a worse outcome.
DES Score
Time frame: 4 weeks post intervention completion
This questionnaire is given to determine if there were any changes in participants' activity level 4 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
DES score
Time frame: 8 weeks post baseline
This questionnaire is given 8 weeks post baseline in order to determine any improvements made during the intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
DES Score
Time frame: 8 weeks post intervention completion
This questionnaire is given to determine if there were any changes in participants' activity level 8 weeks post intervention. Score ranges from 1 to 5, with 1 denoting a worse outcome.
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 3 Nov 2021.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available after deidentification.
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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.
Julienne Kirk, PharmD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dance and diabetes education in people with Diabetes and Pre Diabetes, run by Wake Forest University Health Sciences 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 2 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 3 Nov 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?
National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation (time frame: baseline). The study lists 16 primary outcomes in all. 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 3 Nov 2021.