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

December 20, 2013 updated by: Giulio Marchesini R., M.D., University of Bologna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Unit of Metabolic Diseases and Clinical Dietetics, "Alma Mater Studiorum" University
    • Brescia
      • Gavardo, Brescia, Italy, 25085
        • Unit of Endocrinology and Diabetology, General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Collaborators

Villa Garda Hospital
General Hospital, Gavardo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 27, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BALLANDO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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