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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04427982
Other study ID # IRB00065214
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2020
Est. completion date May 3, 2021

Study information

Verified date October 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This study will assess whether a group dance workshop along with diabetes education can help people with diabetes and prediabetes.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 3, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adults proficient in English with diabetes or prediabetes - subjects who have an established healthcare provider Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
dance
Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.
diabetes education
The dance classes will be followed by a brief diabetes education and discussion session.

Locations

Country Name City State
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Weight measured in kilograms 8 weeks post intervention completion
Other Body Mass Index (BMI) Weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. 8 weeks post intervention completion
Other Glycated Hemoglobin (A1c) The A1c test is a blood test that provides information about average levels of blood glucose over the past 3 months. The A1c test can be used to diagnose type 2 diabetes and prediabetes. The A1c test result is reported as a percentage. The higher the percentage, the higher the blood glucose levels have been. A normal A1c level is below 5.7 percent 8 weeks post intervention completion
Primary 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 baseline
Primary NHANES 2019-2020 PAQ--Days Active Average number of days subjects report being active baseline
Primary NHANES 2019-2020 PAQ--minutes active Average number of minutes (10-60) per day that participants engage in activity baseline
Primary NHANES 2019-2020 PAQ--Activity Confirmation Percentage of subjects who confirm that they are physically active in questionnaire 4 weeks post intervention completion
Primary NHANES 2019-2020 PAQ--Days Active Average number of days subjects report being active 4 weeks post intervention completion
Primary NHANES 2019-2020 PAQ--minutes active Average number of minutes (10-60) per day that participants engage in activity 4 weeks post intervention completion
Primary NHANES 2019-2020 PAQ--Activity Confirmation Percentage of subjects who confirm that they are physically active in questionnaire 8 weeks post baseline
Primary NHANES 2019-2020 PAQ--Days Active Average number of days subjects report being active 8 weeks post baseline
Primary NHANES 2019-2020 PAQ--minutes active Average number of minutes (10-60) per day that participants engage in activity 8 weeks post baseline
Primary NHANES 2019-2020 PAQ--Activity Confirmation Percentage of subjects who confirm that they are physically active in questionnaire 8 weeks post intervention completion
Primary NHANES 2019-2020 PAQ--Days Active Average number of days subjects report being active 8 weeks post intervention completion
Primary NHANES 2019-2020 PAQ--minutes active Average number of minutes (10-60) per day that participants engage in activity 8 weeks post intervention completion
Primary Diabetes Empowerment Scale (DES) score Score ranges from 1 to 5, with 1 denoting a worse outcome. baseline
Primary 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. 4 weeks post intervention completion
Primary 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. 8 weeks post baseline
Primary 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. 8 weeks post intervention completion
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