Dance and Diabetes/Prediabetes Self-Management

NCT04427982 | Completed

• 1 other identifier: IRB00065214
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Pre Diabetes

Keywords

dance; reduce blood sugar; prevention

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (3)

• Weight

  8 weeks post intervention completion

• Body Mass Index (BMI)

  8 weeks post intervention completion

• Glycated Hemoglobin (A1c)

  8 weeks post intervention completion

Study Arms (1)

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.

Behavioral: dance; Behavioral: diabetes education

Interventions

dance BEHAVIORAL

Participants will attend a 2-month weekly light-to-moderate intensity dance workshop.

Experimental Group

diabetes education BEHAVIORAL

The dance classes will be followed by a brief diabetes education and discussion session.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults proficient in English with diabetes or prediabetes
• subjects who have an established healthcare provider

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Julienne Kirk, PharmD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive the dance and education interventions.

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: September 3, 2020
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All data will be available immediately following publication without end date.
• Access Criteria: Information will be available to anyone who wishes to access the data for any purpose.

Locations

US (1)