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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

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date December 27, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Standard Ballroom and Latin Dance Program in Type 2 Diabetes and Obesity
Official Title  ICMJE A Standard Ballroom and Latin Dance Program to Improve Fitness and Adherence to Physical Activity in Individuals With Type 2 Diabetes and Obesity
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes
  • Obesity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: ballroom and Latin dance program
    two-hour dancing session twice a week
    Intervention: Behavioral: Dance program
  • Active Comparator: Self-selected physical activity
    self-selected program of physical activity
    Intervention: Behavioral: Self-selected physical activity
Publications * Mangeri F, Montesi L, Forlani G, Dalle Grave R, Marchesini G. A standard ballroom and Latin dance program to improve fitness and adherence to physical activity in individuals with type 2 diabetes and in obesity. Diabetol Metab Syndr. 2014 Jun 22;6:74. doi: 10.1186/1758-5996-6-74. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2013)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021890
Other Study ID Numbers  ICMJE BALLANDO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giulio Marchesini R., M.D., University of Bologna
Study Sponsor  ICMJE University of Bologna
Collaborators  ICMJE
  • General Hospital, Gavardo
  • Villa Garda Hospital
Investigators  ICMJE Not Provided
PRS Account University of Bologna
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP