An innovative model for changing the lifestyles of persons with obesity and/or type 2 diabetes mellitus

Not Applicable

Recruiting

• Conditions: obesity; type 2 diabetes; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12611000255987
• Lead Sponsor: mbria Region Health Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

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

Exclusion Criteria

concomitant diseases contraindicating physical exercise

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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[1 year<br>5 years]

Secondary Outcome Measures

Name	Time	Method
reduction of HBA1c levels.<br>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.[1 year<br>5 years];reduction of cardiovascular disease risk.<br>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.[1 year<br>5 years];improved quality of life.<br>It will be measured using SF-36 Health Survey. web site:http://www.iqola.org/instruments.aspx#sf36[1 year<br>5 years]