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Trial registered on ANZCTR


Registration number
ACTRN12611000255987
Ethics application status
Approved
Date submitted
4/03/2011
Date registered
8/03/2011
Date last updated
8/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An innovative model for changing the lifestyles of persons with obesity and/or type 2 diabetes mellitus
Scientific title
Effect on energy expenditure and weight of an innovative 7-step intervention model for changing the lifestyles of persons with obesity and/or type 2 diabetes mellitus
Secondary ID [1] 259737 0
Nil
Universal Trial Number (UTN)
U1111-1119-7620
Trial acronym
CURIAMO MODEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 261318 0
type 2 diabetes 261319 0
Condition category
Condition code
Diet and Nutrition 259468 259468 0 0
Obesity
Metabolic and Endocrine 259469 259469 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the CURIAMO project is to validate the short and long-term efficacy of a multidisciplinary model lifestyle intervention in obesity and type 2 diabetes.
Research Design and Methods: Over a three year period, about 1000 adults will be enrolled: 70% with overweight or obesity and 30% with type 2 diabetes (overweight or
obese). Inclusion criteria include: age between 18 and 80 years old, BMI over 27 kg/m2 and/or a diagnosis of type 2 diabetes mellitus; participants will be divided in three age
groups (18-45; 45-65; 65-80 years old). Study duration will be 5 years: 1 year of intervention followed by a mean follow-up period of 4 years. In the first years, after a four
month intensive lifestyle intervention, subjects will follow a maintenance program. During the maintenance program subjects will repeat every four months medical examination, nutritional and psychological counseling in total for approximately 90 minutes and will receive reinforcement for the achieved results. The intervention includes seven steps and involves the following experts: endocrinologists, sport medicine doctors or cardiologists, psychologists, dieticians, educators, nurses,exercise physiologists, and promoters of outdoor activities.
Results: The primary outcome of the study is measuring the efficacy of the lifestyle improvement intervention, defined as a loss of at least 7% of body weight combined with
an increase of at least 10 MET/h-1.week-1 of energy expenditure by physical activity, after 1 year and during the follow-up. Cost/utility analysis of the model will be made in
participants with diabetes.
Intervention code [1] 264169 0
Lifestyle
Comparator / control treatment
The study is not randomized; we will extract case controls from a database from the same health department of patients followed using standard care. The year range of patient data being extracted will be 2008-2012.
Control group
Active

Outcomes
Primary outcome [1] 262280 0
The primary outcome of the study is measuring the efficacy of the lifestyle improvement intervention, defined as a loss of at least 7% of body weight combined with an increase of at least 10 MET/h-1.week-1 of energy expenditure by physical activity.
Energy expenditure will be measured using IPAQ, International Physical Activity Questionnaire. Reference: Craig, CL, Marshall, AL, Sjostrom, M, et al. International Physical Activity Questionnaire: 12-Country Reliability and Validity. Med. Sci. Sports Exerc. 2003, 35: 1381-1395
Timepoint [1] 262280 0
1 year
5 years
Secondary outcome [1] 273446 0
reduction of HBA1c levels.
HBA1c will be measured by High Performance Liquid Chromatography, as previously described in the following literature. Reference: Di Loreto C, Fanelli C, Lucidi P, et al. Make your diabetic patients walk: long-term impact of different amounts of physical activity on type 2 diabetes. Diabetes Care 2005, 28:1295-302.
Timepoint [1] 273446 0
1 year
5 years
Secondary outcome [2] 273447 0
reduction of cardiovascular disease risk.
CVD risk is estimated using UKPDS tables for coronary events and ischemic stroke. reference: Stevens RJ, Kothari V, Adler AI, Stratton IM, Holman RR, on behalf of the United Kingdom Prospective Diabetes Study. (UKPDS) Group. The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56). Clin Science 2001, 101: 671 , 679.
Timepoint [2] 273447 0
1 year
5 years
Secondary outcome [3] 273448 0
improved quality of life.
It will be measured using SF-36 Health Survey. web site:http://www.iqola.org/instruments.aspx#sf36
Timepoint [3] 273448 0
1 year
5 years

Eligibility
Key inclusion criteria
~700 male and female adult participants with BMI
over 27 kg/m2, and ~300 male and female participants with type 2 diabetes (overweight or obese). Inclusion criteria are: age between 18 and 80 years old, BMI over 27 kg/m2 and/or
a diagnosis of type 2 diabetes mellitus
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
concomitant diseases contraindicating physical exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3292 0
Italy
State/province [1] 3292 0

Funding & Sponsors
Funding source category [1] 264618 0
Government body
Name [1] 264618 0
Umbria Region Health Department
Address [1] 264618 0
Corso Vannucci, 96
06121 Perugia
Country [1] 264618 0
Italy
Primary sponsor type
Government body
Name
Umbria Region Health Department
Address
Corso Vannucci, 96
06121 Perugia
Country
Italy
Secondary sponsor category [1] 263755 0
University
Name [1] 263755 0
University of Perugia
Address [1] 263755 0
Piazza dell'Universita,1
06100 Perugia
Country [1] 263755 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260618 0
CEAS, comitato etico aziende sanitarie regione dell'Umbria
Ethics committee address [1] 260618 0
Via della Rivoluzione, 16
06070 Ellera di Corciano (PG)
Ethics committee country [1] 260618 0
Italy
Date submitted for ethics approval [1] 260618 0
Approval date [1] 260618 0
10/01/2010
Ethics approval number [1] 260618 0
1/10/1633

Summary
Brief summary
This study is conducted to establish the efficacy of a new multidisciplinary model in improving body weight and habitual exercise in obesity and type 2 diabetes. The intervention involves several professional figures, medical doctors, exercise physiologists, dieticians, nurses, and psychologists.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32313 0
Address 32313 0
Country 32313 0
Phone 32313 0
Fax 32313 0
Email 32313 0
Contact person for public queries
Name 15560 0
PIERPAOLO DE FEO
Address 15560 0
CURIAMO
VIA G. BAMBAGIONI, 19
06126 PERUGIA
Country 15560 0
Italy
Phone 15560 0
+39 3485244811
Fax 15560 0
Email 15560 0
pierpaolodefeo@gmail.com
Contact person for scientific queries
Name 6488 0
PIERPAOLO DE FEO
Address 6488 0
CURIAMO
VIA G. BAMBAGIONI, 19
06126 PERUGIA
Country 6488 0
Italy
Phone 6488 0
+39 3485244811
Fax 6488 0
Email 6488 0
pierpaolodefeo@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results