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Completed

NCT Number: NCT04427982

Dance and Diabetes/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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

dance

Behavioral

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

Diabetes education

Behavioral

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

Primary outcomes

  1. National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation

    Time frame: baseline

    Percentage of subjects who confirm that they are physically active in questionnaire

  2. NHANES 2019-2020 PAQ--Days Active

    Time frame: baseline

    Average number of days subjects report being active

  3. NHANES 2019-2020 PAQ--minutes active

    Time frame: baseline

    Average number of minutes (10-60) per day that participants engage in activity

  4. NHANES 2019-2020 PAQ--Activity Confirmation

    Time frame: 4 weeks post intervention completion

    Percentage of subjects who confirm that they are physically active in questionnaire

  5. NHANES 2019-2020 PAQ--Days Active

    Time frame: 4 weeks post intervention completion

    Average number of days subjects report being active

  6. NHANES 2019-2020 PAQ--minutes active

    Time frame: 4 weeks post intervention completion

    Average number of minutes (10-60) per day that participants engage in activity

  7. NHANES 2019-2020 PAQ--Activity Confirmation

    Time frame: 8 weeks post baseline

    Percentage of subjects who confirm that they are physically active in questionnaire

  8. NHANES 2019-2020 PAQ--Days Active

    Time frame: 8 weeks post baseline

    Average number of days subjects report being active

  9. NHANES 2019-2020 PAQ--minutes active

    Time frame: 8 weeks post baseline

    Average number of minutes (10-60) per day that participants engage in activity

  10. NHANES 2019-2020 PAQ--Activity Confirmation

    Time frame: 8 weeks post intervention completion

    Percentage of subjects who confirm that they are physically active in questionnaire

  11. NHANES 2019-2020 PAQ--Days Active

    Time frame: 8 weeks post intervention completion

    Average number of days subjects report being active

  12. NHANES 2019-2020 PAQ--minutes active

    Time frame: 8 weeks post intervention completion

    Average number of minutes (10-60) per day that participants engage in activity

  13. Diabetes Empowerment Scale (DES) score

    Time frame: baseline

    Score ranges from 1 to 5, with 1 denoting a worse outcome.

  14. DES Score

    Time frame: 4 weeks post intervention completion

    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.

  15. DES score

    Time frame: 8 weeks post baseline

    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.

  16. DES Score

    Time frame: 8 weeks post intervention completion

    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.

Other outcomes

  1. Weight

    Time frame: 8 weeks post intervention completion

    measured in kilograms

  2. Body Mass Index (BMI)

    Time frame: 8 weeks post intervention completion

    Weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.

  3. Glycated Hemoglobin (A1c)

    Time frame: 8 weeks post intervention completion

    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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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