Dance and Diabetes/Prediabetes Self-Management

Diabetes Clinical Trial

Official title:

Dance as an Intervention to Improve Diabetes and Prediabetes Self-Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427982
• Other study ID #: IRB00065214
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

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