Efficacy Study of Standard Ballroom and Latin Dance Program in Type 2 Diabetes and Obesity

Study Overview
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Brief Summary
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to test the metabolic and clinical effects of a 6-month program of dancing in subjects with type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units. Self-selection of the leisure time activity program was allowed to increase adherence to the physical activity programs.

Official Title
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A Standard Ballroom and Latin Dance Program to Improve Fitness and Adherence to Physical Activity in Individuals With Type 2 Diabetes and Obesity

Conditions
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Diabetes, Obesity

Intervention / Treatment
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* Behavioral: Dance program
* Behavioral: Self-selected physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes in fairly good metabolic control (glycosylated hemoglobin (HbA1c) < 8.5%) and/or obesity (Body Mass Index (BMI) ≥ 30 kg/m2 or waist circumference >94 cm in males, >80 in females), with/without prediabetes or minor alterations of HbA1c. Exclusion Criteria: previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ballroom and Latin dance program<br>two-hour dancing session twice a week | Behavioral: Dance program<br>* two-hour dancing session twice a week, led by instructors in a private hall of a disco. Both solo and partner and group dances were performed during each session: an initial one-hour activity, chaired by two instructors who taught new steps and choreographies to patients (both individually and in group), was followed by a second hour, when patients danced in pairs both Latin and standard ballroom music<br>|
| Active Comparator: Self-selected physical activity<br>self-selected program of physical activity | Behavioral: Self-selected physical activity<br>* gym sessions (with the support of sports associations), exercising at home (cycling, stepping) or walking, jogging or cycling outside with/without group support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5% reduction in BMI or waist circumference |  | 3 months | 
| 5% reduction in BMI or waist circumference |  | 6 months | 
| improved physical fitness (physical activity exceeding 10 MET-hour/week |  | 3 months | 
| improved physical fitness (physical activity exceeding 10 MET-hour/week |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0.3% reduction of HbA1c in the presence of diabetes |  | 3 months | 
| 0.3% reduction of HbA1c in the presence of diabetes |  | 6 months | 
| 10% increase in 6-min walk test |  | 3 months | 
| 10% increase in 6-min walk test |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dance, Physical activity, Physical fitness, Weight loss