Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000488202
Ethics application status
Approved
Date submitted
23/05/2009
Date registered
18/06/2009
Date last updated
18/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Weight Management Program for People with Cardiac Disease and Diabetes
Scientific title
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?
Universal Trial Number (UTN)
Trial acronym
WMPCDD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
weight management in people with existing coronary heart disease and/or type 2 diabetes mellitus 4845 0
Condition category
Condition code
Cardiovascular 237190 237190 0 0
Coronary heart disease
Metabolic and Endocrine 237191 237191 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 236627 0
Lifestyle
Comparator / control treatment
Usual care: Phase III cardiac rehabilitation or diabetes education service, standard services offered by the North Shore Cardiovascular Education Centre (NSCEC) and Diabetes Education Centre (DEC). Therefore people with cardiac disease on the wait-list may choose to attend the regular six week cardiac rehabilitation program which includes six group-based sessions of one-hour duration on cardiac disease, exercise, nutrition, stress and medications; as well as two structured exercise sessions per week. People with diabetes may choose to attend the Diabetes Education Centre program of two group-based sessions of four hours length on diabetes, diet, exercise and monitoring. The control group will be offered the intervention following the 16 week data collection.
Control group
Active

Outcomes
Primary outcome [1] 238006 0
Proportion of participants who achieve a 5% weight loss.Weight will be measured using a single Seca Physicians? Digital weight scale, which is regularly maintained and has been calibrated by the Royal North Shore Hospital Engineering Department.
Timepoint [1] 238006 0
16 weeks and 12 months
Primary outcome [2] 238081 0
Weight loss
Timepoint [2] 238081 0
16 weeks and 12 months
Secondary outcome [1] 242142 0
Readiness to change to achieve weight loss will be assessed using the Stages of change for weight loss questionnaire (SOCWLQ), which is a modification of a tool developed by Sutton et al 32 with the addition of one item from Macqueen et al 33 (Appendix F). The questionnaire consists of 2 parts, with the first containing 5 items addressing weight loss behaviours for exercise and nutrition. Participants respond using a 6-point scale that corresponds with the different stages of change expressed in Prochaska and Diclementes? Transtheoretical Model of Change. Part 2 has one item that reflects the participants? current state and participants respond by choosing one of 6 items from the model. Therefore scoring of items will occur so that every response from 3-5 indicates an active stage and therefore gains a score of 1, whereas any response of 1, 2 or 6 is an inactive stage and therefore has a score of 0. Scores will then be totaled for a potential score from 0 (not actively changing) to 5 (actively changing). This questionnaire was also pilot-tested on 18 patients attending the DEC, demonstrating ease of use, a diverse range of scores. Reliability could not be tested as responses are not interval scale.
Timepoint [1] 242142 0
16 weeks and 12 months
Secondary outcome [2] 242144 0
Exercise participation in minutes for the previous week using a standard 1 week diary and standard Omron pedomter
Timepoint [2] 242144 0
16 weeks and 12 months
Secondary outcome [3] 242145 0
Meters walked in 6 minutes . The six-minute walk test (6MWT) is a submaximal test of aerobic capacity and exercise endurance by measuring the maximum distance a person can walk in 6 minutes. The 6MWT is commonly used to assess function in cardiovascular patients and is recommended because of its similarity to people?s normal activity and ease of administration. The 6MWT has been demonstrated to have good test-retest reliability and construct validity in older patients.29 In this study the 6MWT will be conducted using the standardized method suggested by Steffen et al 29 of 2 trials with an intervening rest period
Timepoint [3] 242145 0
16 weeks and 12 months
Secondary outcome [4] 242274 0
Self-efficacy for weight loss (Self-efficacy for Weight Loss Questionnaire) which is a modification of a tool developed by Linde et al 30 and Clark et al 31. Modifications to the tool were to ensure consistency with Australian dietary and physical guidelines and Australian vernacular (Appendix E). The questionnaire consists of 12 items related to confidence for several aspects of weight loss including exercise, nutrition and the effects of different contexts. Participants respond using a 5-point scale from 1 (not at all confident) to 5 (very confident). Responses from the 12 items are totaled for a score from 12 to 60, with higher scores reflecting more confidence. This questionnaire was pilot-tested on 18 patients attending the DEC, demonstrating high internal reliability (Cronbach?s Alpha .88), a diverse range of scores and ease of use.
Timepoint [4] 242274 0
16 weeks and 12 months
Secondary outcome [5] 242275 0
Readiness to change - weight management. Readiness to change to achieve weight loss will be assessed using the Stages of change for weight loss questionnaire (SOCWLQ), which is a modification of a tool developed by Sutton et al 32 with the addition of one item from Macqueen et al 33 (Appendix F). The questionnaire consists of 2 parts, with the first containing 5 items addressing weight loss behaviours for exercise and nutrition. Participants respond using a 6-point scale that corresponds with the different stages of change expressed in Prochaska and Diclementes? Transtheoretical Model of Change. Part 2 has one item that reflects the participants? current state and participants respond by choosing one of 6 items from the model. Therefore scoring of items will occur so that every response from 3-5 indicates an active stage and therefore gains a score of 1, whereas any response of 1, 2 or 6 is an inactive stage and therefore has a score of 0. Scores will then be totaled for a potential score from 0 (not actively changing) to 5 (actively changing). This questionnaire was also pilot-tested on 18 patients attending the DEC, demonstrating ease of use, a diverse range of scores. Reliability could not be tested as responses are not interval scale.
Timepoint [5] 242275 0
16 weeks and 12 months
Secondary outcome [6] 242276 0
Waist circumference loss. Waist circumference will be measured using a single measuring tape supplied by the World Heart Federation (WHF) for the purpose. Following WHF recommendations, waist circumference will be measured by positioning the tape halfway between the top of the iliac crest and rib 10. Participants will be asked to relax their abdomen and breathe out softly. A secondary measure will be taken using a set distance from the sternal notch for the first 3 groups and the most consistent measure used for the remainder of the trial. All measures will be taken twice and a mean calculated.
Timepoint [6] 242276 0
16 weeks and 12 months

Eligibility
Key inclusion criteria
Diagnosed with coronary heart disease or type 2 diabetes mellitus, body mass index between 27 to 35, able to participate in regular exercise
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major psychiatric illness, cognitive limitations, difficulty with understanding English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are registered following informed consent by phone call from the project manager at the NSCEC or DEC (at the hospital) providing the name, age and gender of the participant to the chief investigator (who is independent of the treatment team). The Chief Investigator (Robyn Gallagher) then registers the participant and allocates the participant randomly to treatment or control groups, and the project manager then confirms allocation with the participant who is provided with information regarding any further actions they need to take.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number tables, with randomisation occurring in blocks of 20 participants as the intervention is group based.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The control/usual care group is a wait-list to avoid disappointment
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5006 0
University
Name [1] 5006 0
University of Technology, Sydney Challenge Grant
Country [1] 5006 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
Faculty of Nursing, Midwifery and Health
University of Technology, Sydney
PO Box 123 Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 4595 0
Hospital
Name [1] 4595 0
Royal North Shore Hospital
Address [1] 4595 0
Pacific Highway
StLeonards NSW2065
Country [1] 4595 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7107 0
Harbour Northern Sydney Central Coast Ethics Committe
Ethics committee address [1] 7107 0
Ethics committee country [1] 7107 0
Australia
Date submitted for ethics approval [1] 7107 0
Approval date [1] 7107 0
13/10/2008
Ethics approval number [1] 7107 0
08/HARBR/112/113
Ethics committee name [2] 7108 0
University of Technology, Sydne
Ethics committee address [2] 7108 0
Ethics committee country [2] 7108 0
Australia
Date submitted for ethics approval [2] 7108 0
Approval date [2] 7108 0
18/12/2008
Ethics approval number [2] 7108 0
2008-332

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29640 0
Address 29640 0
Country 29640 0
Phone 29640 0
Fax 29640 0
Email 29640 0
Contact person for public queries
Name 12887 0
Robyn Gallagher
Address 12887 0
Faculty of Nursing, Midwifery and Health
University of Technology, Sydney
PO Box 123 Broadway NSW 2007
Country 12887 0
Australia
Phone 12887 0
61 2 9514 4833
Fax 12887 0
Email 12887 0
[email protected]
Contact person for scientific queries
Name 3815 0
Robyn Gallagher
Address 3815 0
Faculty of Nursing, Midwifery and Health
University of Technology, Sydney
PO Box 123 Broadway NSW 2007
Country 3815 0
Australia
Phone 3815 0
61 2 9514 4833
Fax 3815 0
Email 3815 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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