Clinical trial NCT04427982: Dance and Diabetes/Prediabetes Self-Management
Official title: Dance as an Intervention to Improve Diabetes and Prediabetes Self-Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Pre Diabetes
Keywords: dance
reduce blood sugar
prevention
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive the dance and education interventions.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: National Health and Nutrition Examination Survey Physical Activity and Physical Fitness Questionnaire (NHANES 2019-2020 PAQ)--Activity Confirmation
timeFrame: baseline
measure: NHANES 2019-2020 PAQ--Days Active
timeFrame: baseline
measure: NHANES 2019-2020 PAQ--minutes active
timeFrame: baseline
measure: NHANES 2019-2020 PAQ--Activity Confirmation
timeFrame: 4 weeks post intervention completion
measure: NHANES 2019-2020 PAQ--Days Active
timeFrame: 4 weeks post intervention completion
measure: NHANES 2019-2020 PAQ--minutes active
timeFrame: 4 weeks post intervention completion
measure: NHANES 2019-2020 PAQ--Activity Confirmation
timeFrame: 8 weeks post baseline
measure: NHANES 2019-2020 PAQ--Days Active
timeFrame: 8 weeks post baseline
measure: NHANES 2019-2020 PAQ--minutes active
timeFrame: 8 weeks post baseline
measure: NHANES 2019-2020 PAQ--Activity Confirmation
timeFrame: 8 weeks post intervention completion
measure: NHANES 2019-2020 PAQ--Days Active
timeFrame: 8 weeks post intervention completion
measure: NHANES 2019-2020 PAQ--minutes active
timeFrame: 8 weeks post intervention completion
measure: Diabetes Empowerment Scale (DES) score
timeFrame: baseline
measure: DES Score
timeFrame: 4 weeks post intervention completion
measure: DES score
timeFrame: 8 weeks post baseline
measure: DES Score
timeFrame: 8 weeks post intervention completion
Secondary outcomes:
Other outcomes:
measure: Weight
timeFrame: 8 weeks post intervention completion
measure: Body Mass Index (BMI)
timeFrame: 8 weeks post intervention completion
measure: Glycated Hemoglobin (A1c)
timeFrame: 8 weeks post intervention completion
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Julienne Kirk, PharmD
role: PRINCIPAL_INVESTIGATOR
References: