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Dance and Diabetes/Prediabetes Self-Management

Primary Purpose

Diabetes, Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dance
diabetes education
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring dance, reduce blood sugar, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

All participants will attend a 2-month weekly light-to-moderate intensity dance workshop followed by a brief diabetes education and discussion session.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2020
Last Updated
October 26, 2021
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04427982
Brief Title
Dance and Diabetes/Prediabetes Self-Management
Official Title
Dance as an Intervention to Improve Diabetes and Prediabetes Self-Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pre Diabetes
Keywords
dance, reduce blood sugar, prevention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants receive the dance and education interventions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
All participants will attend a 2-month weekly light-to-moderate intensity dance workshop followed by a brief diabetes education and discussion session.
Intervention Type
Behavioral
Intervention Name(s)
dance
Intervention Description
Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.
Intervention Type
Behavioral
Intervention Name(s)
diabetes education
Intervention Description
The dance classes will be followed by a brief diabetes education and discussion session.
Primary Outcome Measure Information:
Title
National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation
Description
Percentage of subjects who confirm that they are physically active in questionnaire
Time Frame
baseline
Title
NHANES 2019-2020 PAQ--Days Active
Description
Average number of days subjects report being active
Time Frame
baseline
Title
NHANES 2019-2020 PAQ--minutes active
Description
Average number of minutes (10-60) per day that participants engage in activity
Time Frame
baseline
Title
NHANES 2019-2020 PAQ--Activity Confirmation
Description
Percentage of subjects who confirm that they are physically active in questionnaire
Time Frame
4 weeks post intervention completion
Title
NHANES 2019-2020 PAQ--Days Active
Description
Average number of days subjects report being active
Time Frame
4 weeks post intervention completion
Title
NHANES 2019-2020 PAQ--minutes active
Description
Average number of minutes (10-60) per day that participants engage in activity
Time Frame
4 weeks post intervention completion
Title
NHANES 2019-2020 PAQ--Activity Confirmation
Description
Percentage of subjects who confirm that they are physically active in questionnaire
Time Frame
8 weeks post baseline
Title
NHANES 2019-2020 PAQ--Days Active
Description
Average number of days subjects report being active
Time Frame
8 weeks post baseline
Title
NHANES 2019-2020 PAQ--minutes active
Description
Average number of minutes (10-60) per day that participants engage in activity
Time Frame
8 weeks post baseline
Title
NHANES 2019-2020 PAQ--Activity Confirmation
Description
Percentage of subjects who confirm that they are physically active in questionnaire
Time Frame
8 weeks post intervention completion
Title
NHANES 2019-2020 PAQ--Days Active
Description
Average number of days subjects report being active
Time Frame
8 weeks post intervention completion
Title
NHANES 2019-2020 PAQ--minutes active
Description
Average number of minutes (10-60) per day that participants engage in activity
Time Frame
8 weeks post intervention completion
Title
Diabetes Empowerment Scale (DES) score
Description
Score ranges from 1 to 5, with 1 denoting a worse outcome.
Time Frame
baseline
Title
DES Score
Description
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.
Time Frame
4 weeks post intervention completion
Title
DES score
Description
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.
Time Frame
8 weeks post baseline
Title
DES Score
Description
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.
Time Frame
8 weeks post intervention completion
Other Pre-specified Outcome Measures:
Title
Weight
Description
measured in kilograms
Time Frame
8 weeks post intervention completion
Title
Body Mass Index (BMI)
Description
Weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.
Time Frame
8 weeks post intervention completion
Title
Glycated Hemoglobin (A1c)
Description
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
Time Frame
8 weeks post intervention completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julienne Kirk, PharmD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Dance and Diabetes/Prediabetes Self-Management

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