NCT02021890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
Last Updated

December 27, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

December 20, 2013

Last Update Submit

December 20, 2013

Conditions

DiabetesObesity

Keywords

DancePhysical activityPhysical fitnessWeight loss

Outcome Measures

Primary Outcomes (4)

  • 5% reduction in BMI or waist circumference

    3 months

  • 5% reduction in BMI or waist circumference

    6 months

  • improved physical fitness (physical activity exceeding 10 MET-hour/week

    3 months

  • improved physical fitness (physical activity exceeding 10 MET-hour/week

    6 months

Secondary Outcomes (4)

  • 0.3% reduction of HbA1c in the presence of diabetes

    3 months

  • 0.3% reduction of HbA1c in the presence of diabetes

    6 months

  • 10% increase in 6-min walk test

    3 months

  • 10% increase in 6-min walk test

    6 months

Study Arms (2)

ballroom and Latin dance program

EXPERIMENTAL

two-hour dancing session twice a week

Behavioral: Dance program

Self-selected physical activity

ACTIVE COMPARATOR

self-selected program of physical activity

Behavioral: Self-selected physical activity

Interventions

Dance programBEHAVIORAL

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

ballroom and Latin dance program
Self-selected physical activityBEHAVIORAL

gym sessions (with the support of sports associations), exercising at home (cycling, stepping) or walking, jogging or cycling outside with/without group support

Self-selected physical activity

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unit of Metabolic Diseases and Clinical Dietetics, "Alma Mater Studiorum" University

Bologna, Bologna, 40138, Italy

Location

Unit of Endocrinology and Diabetology, General Hospital

Gavardo, Brescia, 25085, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25045404DERIVED

MeSH Terms

Conditions

Diabetes MellitusObesityMotor ActivityWeight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dietetics

Study Record Dates

First Submitted

December 20, 2013

First Posted

December 27, 2013

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

March 1, 2013

Last Updated

December 27, 2013

Record last verified: 2013-12

Locations

IT(2)