Dance and Diabetes/Prediabetes Self-Management

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Pre Diabetes
• Intervention / Treatment: Behavioral: dance; Behavioral: diabetes education

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; All participants will attend a 2-month weekly light-to-moderate intensity dance workshop followed by a brief diabetes education and discussion session.	Behavioral: dance; Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.; Behavioral: diabetes education; The dance classes will be followed by a brief diabetes education and discussion session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
NHANES 2019-2020 PAQ--Days Active	Average number of days subjects report being active	baseline
NHANES 2019-2020 PAQ--minutes active	Average number of minutes (10-60) per day that participants engage in activity	baseline
NHANES 2019-2020 PAQ--Activity Confirmation	Percentage of subjects who confirm that they are physically active in questionnaire	4 weeks post intervention completion
NHANES 2019-2020 PAQ--Days Active	Average number of days subjects report being active	4 weeks post intervention completion
NHANES 2019-2020 PAQ--minutes active	Average number of minutes (10-60) per day that participants engage in activity	4 weeks post intervention completion
NHANES 2019-2020 PAQ--Activity Confirmation	Percentage of subjects who confirm that they are physically active in questionnaire	8 weeks post baseline
NHANES 2019-2020 PAQ--Days Active	Average number of days subjects report being active	8 weeks post baseline
NHANES 2019-2020 PAQ--minutes active	Average number of minutes (10-60) per day that participants engage in activity	8 weeks post baseline
NHANES 2019-2020 PAQ--Activity Confirmation	Percentage of subjects who confirm that they are physically active in questionnaire	8 weeks post intervention completion
NHANES 2019-2020 PAQ--Days Active	Average number of days subjects report being active	8 weeks post intervention completion
NHANES 2019-2020 PAQ--minutes active	Average number of minutes (10-60) per day that participants engage in activity	8 weeks post intervention completion
Diabetes Empowerment Scale (DES) score	Score ranges from 1 to 5, with 1 denoting a worse outcome.	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.	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.	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.	8 weeks post intervention completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	measured in kilograms	8 weeks post intervention completion
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Julienne Kirk, PharmD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: prevention; dance; reduce blood sugar
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB00065214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial will be available after deidentification.
• IPD Sharing Time Frame: All data will be available immediately following publication without end date.
• IPD Sharing Access Criteria: Information will be available to anyone who wishes to access the data for any purpose.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No