Efficacy Study of Standard Ballroom and Latin Dance Program in Type 2 Diabetes and Obesity (BALLANDO)
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| ClinicalTrials.gov Identifier: NCT02021890 |
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Recruitment Status :
Completed
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
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Sponsor:
University of Bologna
Collaborators:
General Hospital, Gavardo
Villa Garda Hospital
Information provided by (Responsible Party):
Giulio Marchesini R., M.D., University of Bologna
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Obesity | Behavioral: Dance program Behavioral: Self-selected physical activity | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Standard Ballroom and Latin Dance Program to Improve Fitness and Adherence to Physical Activity in Individuals With Type 2 Diabetes and Obesity |
| Study Start Date : | September 2011 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | March 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
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Experimental: ballroom and Latin dance program
two-hour dancing session twice a week
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Behavioral: Dance program
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 |
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Active Comparator: Self-selected physical activity
self-selected program of physical activity
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Behavioral: Self-selected physical activity
gym sessions (with the support of sports associations), exercising at home (cycling, stepping) or walking, jogging or cycling outside with/without group support |
Primary Outcome Measures :
- 5% reduction in BMI or waist circumference [ Time Frame: 3 months ]
- 5% reduction in BMI or waist circumference [ Time Frame: 6 months ]
- improved physical fitness (physical activity exceeding 10 MET-hour/week [ Time Frame: 3 months ]
- improved physical fitness (physical activity exceeding 10 MET-hour/week [ Time Frame: 6 months ]
Secondary Outcome Measures :
- 0.3% reduction of HbA1c in the presence of diabetes [ Time Frame: 3 months ]
- 0.3% reduction of HbA1c in the presence of diabetes [ Time Frame: 6 months ]
- 10% increase in 6-min walk test [ Time Frame: 3 months ]
- 10% increase in 6-min walk test [ Time Frame: 6 months ]
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021890
Locations
| Italy | |
| Unit of Endocrinology and Diabetology, General Hospital | |
| Gavardo, Brescia, Italy, 25085 | |
| Unit of Metabolic Diseases and Clinical Dietetics, "Alma Mater Studiorum" University | |
| Bologna, Italy, 40138 | |
Sponsors and Collaborators
University of Bologna
General Hospital, Gavardo
Villa Garda Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Giulio Marchesini R., M.D., Professor of Dietetics, University of Bologna |
| ClinicalTrials.gov Identifier: | NCT02021890 |
| Other Study ID Numbers: |
BALLANDO |
| First Posted: | December 27, 2013 Key Record Dates |
| Last Update Posted: | December 27, 2013 |
| Last Verified: | December 2013 |
Keywords provided by Giulio Marchesini R., M.D., University of Bologna:
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Dance Physical activity Physical fitness Weight loss |
Additional relevant MeSH terms:
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Diabetes Mellitus Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight |