Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000195459
Ethics application status
Approved
Date submitted
21/03/2007
Date registered
4/04/2007
Date last updated
24/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telephone Intervention for Physical Activity and Dietary Change in Patients with Multiple Chronic Conditions
Scientific title
A cluster randomised trial of a telephone and print intervention for physical activity and dietary change in patients with multiple chronic conditions such as hypertension, type 2 diabetes and cancer
Secondary ID [1] 287978 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LHLP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 1715 0
Type 2 Diabetes 1716 0
Some forms of Cancer (Breast, Colon, Prostate, Endometrial, Bladder, Cervical, Uterine, Rectal, Lymphoma, Non-Hodgkins lymphoma) 1717 0
Condition category
Condition code
Cancer 1806 1806 0 0
Public Health 1807 1807 0 0
Health promotion/education
Cardiovascular 1808 1808 0 0
Hypertension
Metabolic and Endocrine 1809 1809 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group: Participants receive a total of 18 telephone calls over 12 months. Calls are delivered weekly for the first three weeks, fortnightly until four months, and monthly for the remaining eight months. Using data from participants’ baseline assessment, a detailed intervention workbook is prepared and posted to participants prior to the first telephone call. The workbook contains: tailored feedback graphs, showing participants how their levels of physical activity and dietary intake compare to what is recommended; sections on physical activity and diet; information on goal setting, problem-solving, self-rewards, social support, positive self-talk, relapse, and action plans. New tailored graphs are mailed to participants following each study assessment. Using the workbook during the calls, participants work collaboratively with their telephone counsellor to set goals for physical activity and dietary change. Barriers and supports are identified; confidence is assessed and problem-solving is discussed as necessary. These steps are repeated during intervention contacts, with goals being adjusted as necessary. Participants are counselled to meet (or exceed) the recommendation of 150 minutes a week of accumulated moderate activity on five or more days per week. Walking is emphasized, and stretching and strength exercises are also encouraged, consistent with physical activity guidelines for older adults. Dietary advice given to participants centres around the Australian dietary recommendations – five servings per day of vegetables, two servings per day of fruit, < 30% of energy intake from total fat, < 10% of energy intake from saturated fat, and 30grams per day fibre.

The duration of the intervention is 12 months.
Intervention code [1] 1663 0
Lifestyle
Comparator / control treatment
The Control group: After each assessment, usual care participants are sent a thank you letter that includes very brief feedback on their assessment indicating the areas in which they might like to focus. Included in this mailing are standard, off-the-shelf brochures on a range of health behaviours (including diet, physical activity, smoking, alcohol and sun protection), and a project newsletter that updates them on how many people are participating in the study and gives general health tips.
Control group
Active

Outcomes
Primary outcome [1] 2526 0
Minutes of Physical Activity, Sessions of Physical Activity
Timepoint [1] 2526 0
Assessed at baseline, 4months, 12 months and 18 months.
Primary outcome [2] 2527 0
Serves of Fruit
Timepoint [2] 2527 0
Assessed at baseline, 4months, 12 months and 18 months
Primary outcome [3] 2528 0
Serves of Vegetables
Timepoint [3] 2528 0
Assessed at baseline, 4months, 12 months and 18 months.
Primary outcome [4] 2529 0
Fibre Intake
Timepoint [4] 2529 0
Assessed at baseline, 4months, 12 months and 18 months.
Primary outcome [5] 2530 0
Total Fat Intake (% energy)
Timepoint [5] 2530 0
Assessed at baseline, 4months, 12 months and 18 months
Primary outcome [6] 2531 0
Saturated Fat Intake (% energy)
Timepoint [6] 2531 0
Assessed at baseline, 4months, 12 months and 18 months.
Secondary outcome [1] 4371 0
1. Quality of Life: “Quality of Life” will be assessed across eight dimensions – physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, vitality and mental health, using the Short-Form (SF)-36 Version 2 Health Survey.
Timepoint [1] 4371 0
Assessed at baseline, 4 months, 12 months and 18 months.
Secondary outcome [2] 4372 0
2. Community Resource Use: “Community Resource Use” will be measured with the Chronic Illness Resources Survey (CIRS). The CIRS was modified to include items relating only to personal, family and friends, health care providers, neighbourhood and community subscales and excluded the items relating to media and policy and work subscales.
Timepoint [2] 4372 0
Assessed at baseline, 4 months, 12 months, and 18 months.
Secondary outcome [3] 4373 0
3. Satisfaction: “Satisfaction” will be measured using items developed specifically for this study consisting of 5-items relating to helpfulness of the program (overall, program kit, telephone calls, pedometer, strength band); rated on a 10 point scale (1 = not at all helpful – 10 = extremely helpful); and 1 open-ended question on suggestions for improving the program. The control group is asked only 1-item on overall helpfulness and the open-ended item, and the intervention group is asked all items. The open-ended item is only asked at 12-months.
Timepoint [3] 4373 0
Assessed at 4 months, 12 months and 18 months.

Eligibility
Key inclusion criteria
Diagnosis of either hypertension, Type 2 diabetes or some forms of cancer (breast, cervical, colon, uterine, prostate, rectal, endometrial, lymphoma, bladder, non-hodgkins lymphoma); English speaking.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not on insulin; not undergoing active treatment for cancer; not planning hip/knee replacement in next year; not using mobility aid; not with active heart disease; not with breathing problems; not undergoing dialysis; not taking Warfarin; not pregnant.

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2004
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
31/10/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
434
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1960 0
Government body
Name [1] 1960 0
National Health and Medical Research Council
Country [1] 1960 0
Australia
Primary sponsor type
University
Name
School of Population Health, The University of Queensland
Address
The University of Queensland
School of Public Health
Cancer Prevention Research Centre
Level 4, Public Health Building
Herston road, Herston, QLD, 4006
Country
Australia
Secondary sponsor category [1] 1770 0
None
Name [1] 1770 0
Nil
Address [1] 1770 0
Country [1] 1770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3656 0
The University of Queensland
Ethics committee address [1] 3656 0
Ethics committee country [1] 3656 0
Australia
Date submitted for ethics approval [1] 3656 0
Approval date [1] 3656 0
30/03/2004
Ethics approval number [1] 3656 0
2005000639

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

Contacts
Principal investigator
Name 27766 0
Prof Elizabeth Eakin
Address 27766 0
The University of Queensland
School of Public Health
Cancer Prevention Research Centre
Level 4, Public Health Building
Herston road, Herston, QLD, 4006
Country 27766 0
Australia
Phone 27766 0
+61 7 3365 5505
Fax 27766 0
Email 27766 0
[email protected]
Contact person for public queries
Name 10852 0
Elizabeth Eakin
Address 10852 0
The University of Queensland
School of Public Health
Cancer Prevention Research Centre
Level 4, Public Health Building
Herston road, Herston, QLD, 4006
Country 10852 0
Australia
Phone 10852 0
+61 7 3365 5505
Fax 10852 0
+61 7 33655540
Email 10852 0
[email protected]
Contact person for scientific queries
Name 1780 0
Elizabeth Eakin
Address 1780 0
The University of Queensland
School of Public Health
Cancer Prevention Research Centre
Level 4, Public Health Building
Herston road, Herston, QLD, 4006
Country 1780 0
Australia
Phone 1780 0
+61 7 3365 5505
Fax 1780 0
+61 7 33655540
Email 1780 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.