RecruitingPhase 1ACTRN12609000488202

Weight Management Program for People with Cardiac Disease and Diabetes

In people with cardiac disease and type 2 diabetes mellitus does a multidisciplinary intervention involving information and support sessions in combination with structured exercise over 16 weeks result in weight loss?


Sponsor

University of Technology, Sydney

Enrollment

168 participants

Start Date

Jan 5, 2009

Study Type

Interventional

Conditions

Summary

The research outlined in this proposal will trial an innovative multidisciplinary program demonstrated to achieve weight loss in overweight people with cardiac disease and diabetes. The program was developed because obesity is a major health problem in NSW and globally, and even more so in people with heart disease and diabetes. The pilot program resulted in weight loss of 4-5% sustained at 12 months. This weight loss is demonstrated to result in improved risk factors, decreased progression of of disease and improved quality of life.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a multidisciplinary weight management programme for people who are overweight and have been diagnosed with either coronary heart disease or Type 2 diabetes. Being overweight worsens both conditions, and even a modest weight loss of 4-5% can improve risk factors and quality of life. The programme involves a team of health professionals working together to help participants lose weight and keep it off. You may be eligible if: - You are between 18 and 80 years old - You have been diagnosed with coronary heart disease or Type 2 diabetes - Your BMI is between 27 and 35 - You are able to participate in regular exercise You may NOT be eligible if: - You have a major psychiatric illness - You have significant cognitive limitations - You have difficulty understanding English Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

a 16 week program of structured exercise twice/week and multidiscipinary information and support sessions (five) aimed at improving participant's weight management habits The structured exercise incl

a 16 week program of structured exercise twice/week and multidiscipinary information and support sessions (five) aimed at improving participant's weight management habits The structured exercise includes a total of 20 supervised sessions (2 per week) of one hour of planned aerobic exercise and resistance training supervised by expert cardiac rehabilitation staff. The home-based exercise program is tailored by an exercise physiologist at program admission and updated over the first 4 months to include 30-60 minutes of physical activity, including pedometer-recorded steps for the remaining 5 days of the week. The group information and support sessions consist of 4, 90-minute sessions delivered in weeks 1, 2, 4 and 8 of the program. These sessions will be delivered by a multidisciplinary team consisting of a nutritionist, clinical psychologist, exercise physiologist and cardiac rehabilitation clinical nurse consultant. Session content will include information about nutrition and exercise aimed at weight reduction and modified for diabetes mellitus and cardiovascular disease; the health implications of being overweight; behavioural change, potential barriers and strategies for self management. Session processes will be interactive, teaching participants how to use food and exercise diaries, with subsequent sessions using these diaries to help develop the capacity to problem-solve, foster motivation and gain a sense of mastery. All content and processes will be based on behavioural and cognitive behavioural therapy tenets and guided by Social Learning Theory and the Transtheoretical Model of Change. Phase 2 of the program is designed to support participants’ continued weight loss behaviours and strategies and will include a one-hour session at 16 weeks (following the assessment schedule) and telephone follow-by one team member on three occasions between 4 and 12 months. The group session will focus on problem-solving and motivation using similar content and processes to the Phase 1 program.


Locations(1)

Australia

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ACTRN12609000488202