DiabetesBALLANDONCT02021890
Efficacy Study of Standard Ballroom and Latin Dance Program in Type 2 Diabetes and Obesity
A study testing Dance program and Self-selected physical activity in people with Diabetes and Obesity, run by University of Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- What is being tested?
- Dance program and Self-selected physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Unit of Metabolic Diseases and Clinical Dietetics, "Alma Mater Studiorum" University
Bologna, Bologna, 40138
Unit of Endocrinology and Diabetology, General Hospital
Gavardo, Brescia, 25085
About this study
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
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.
- Being tested
- Dance program, Self-selected physical activity
- Keywords
- Dance, Physical activity, Physical fitness, Weight loss
- Medical subject headings
- Diabetes Mellitus, Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance programBehavioural
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
Self-selected physical activityBehavioural
gym sessions (with the support of sports associations), exercising at home (cycling, stepping) or walking, jogging or cycling outside with/without group support
| Study group | Role | What they receive |
|---|---|---|
| ballroom and Latin dance program | Experimental | two-hour dancing session twice a week Receives: Behavioral: Dance program |
| Self-selected physical activity | Active comparator | self-selected program of physical activity Receives: Behavioral: Self-selected physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
5% reduction in BMI or waist circumference
Measured: 3 months
5% reduction in BMI or waist circumference
Measured: 6 months
improved physical fitness (physical activity exceeding 10 MET-hour/week
Measured: 3 months
improved physical fitness (physical activity exceeding 10 MET-hour/week
Measured: 6 months
Secondary outcomes (4)
0.3% reduction of HbA1c in the presence of diabetes
Measured: 3 months
0.3% reduction of HbA1c in the presence of diabetes
Measured: 6 months
10% increase in 6-min walk test
Measured: 3 months
10% increase in 6-min walk test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital, Gavardo, Villa Garda Hospital
- Responsible party
- Principal investigator, Giulio Marchesini R., M.D., University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021890
- Sponsor's protocol ID
- BALLANDO
- Acronym
- BALLANDO
- Status last verified
- Dec 2013
- First submitted
- 20 Dec 2013
- Last updated
- 27 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25045404
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02021890
- Acronym / sponsor ID
- BALLANDO / BALLANDO
- Keywords
- Dance, Physical activity, Physical fitness, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- General Hospital, Gavardo, Villa Garda Hospital
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ballroom and Latin dance program | Experimental | Behavioral: Dance programtwo-hour dancing session twice a week |
| Self-selected physical activity | Active comparator | Behavioral: Self-selected physical activityself-selected program of physical activity |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance programtwo-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 | Behavioural | ballroom and Latin dance program |
| Self-selected physical activitygym sessions (with the support of sports associations), exercising at home (cycling, stepping) or walking, jogging or cycling outside with/without group support | Behavioural | Self-selected physical activity |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
- Derived from this study: PubMed 25045404Mangeri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance program and Self-selected physical activity in people with Diabetes and Obesity, run by University of Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5% reduction in BMI or waist circumference (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02021890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2013.