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

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ClinicalTrials.gov Identifier: NCT02021890
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Collaborators:
General Hospital, Gavardo
Villa Garda Hospital
Information provided by (Responsible Party):
Giulio Marchesini R., M.D., University of Bologna

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

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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


Arm Intervention/treatment
Experimental: ballroom and Latin dance program
two-hour dancing session twice a week
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

Active Comparator: Self-selected physical activity
self-selected program of physical activity
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 :
  1. 5% reduction in BMI or waist circumference [ Time Frame: 3 months ]
  2. 5% reduction in BMI or waist circumference [ Time Frame: 6 months ]
  3. improved physical fitness (physical activity exceeding 10 MET-hour/week [ Time Frame: 3 months ]
  4. improved physical fitness (physical activity exceeding 10 MET-hour/week [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 0.3% reduction of HbA1c in the presence of diabetes [ Time Frame: 3 months ]
  2. 0.3% reduction of HbA1c in the presence of diabetes [ Time Frame: 6 months ]
  3. 10% increase in 6-min walk test [ Time Frame: 3 months ]
  4. 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
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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):
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Responsible Party: Giulio Marchesini R., M.D., Professor of Dietetics, University of Bologna
ClinicalTrials.gov Identifier: NCT02021890     History of Changes
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:
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
Signs and Symptoms