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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 1960 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Australia
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
This 4-year, cluster-randomised trial is evaluating a 12-month, telephone-delivered physical activity and dietary behaviour intervention targeting low-income patients with type 2 diabetes and hypertension, recruited from the primary care setting, and compared to usual care. A systematic evaluation of the incremental costs will be undertaken; and data on program adoption, reach and implementation will be evaluated in order to identify factors relevant to the translation and generalisability of this intervention approach.
Trial website
Trial related presentations / publications
Papers:

Eakin EG, Reeves MM, Lawler SP, Oldenburg B, Del Mar C, Wilkie K, Spencer A, Battistutta D, Graves N. The Logan Healthy Living Program: A cluster randomized trial of a telephone-delivered physical activity and dietary behavior intervention for primary care patients with type 2 diabetes or hypertension from a socially disadvantaged community – rationale, design and recruitment. Contemporary Clinical Trials, 2008;29(3):439-454.

Eakin E, Reeves M, Lawler S, Graves N, Oldenburg B, Del Mar C, Wilkie K, Winkler E, Barnett A. Telephone counseling for physical activity and diet in primary care patients. American Journal of Preventive Medicine. 2009;36(2):142-149.

Graves N, Barnett AG, Halton KA, Veerman JL, Winkler E, Owen N, Reeves MM, Marshall A, Eakin E. Cost-effectiveness of a telephone-delivered intervention for physical activity and diet. PLoS ONE. 2009;4(9):e7135.

Eakin E, Reeves M, Winkler E, Lawler S, Owen N. Maintenance of physical activity and dietary change following a telephone-delivered intervention. Health Psychology, 2010:29(6):566-573.

Lawler SP, Winkler E, Reeves MM, Owen N, Graves N, Eakin EG. Multiple health behavior changes and co-variation in a telephone counseling trial. Annals of Behavioral Medicine, 2010;39(3):250-257.

Reeves MM, Marshall AL, Owen N, Winkler EA, Eakin EG. Measuring physical activity change in broad-reach intervention trials. Journal of Physical Activity and Health. 2010;7(2):194-202.

Goode A D, Winkler EA, Lawler SP, Reeves MM, Owen N, Eakin EG. A telephone-delivered physical activity and dietary intervention for type 2 diabetes and hypertension: Does intervention dose influence outcomes? American Journal of Health Promotion, 2011: 25(4): 257-263.

Waters LA, Reeves MM, Fjeldsoe BS, Eakin EG. Characteristics of control group participants who increased their physical activity in a cluster-randomized lifestyle intervention trial. BMC Public Health, 2011:11:27.

Waters LA, Winkler EA, Reeves MM, Fjeldsoe BS, Eakin EG. The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial. International Journal of Behavioral Nutrition and Physical Activity, 2011: 8:24.

Goode AD, Owen N, Reeves MM, Eakin EG. Translation from research to practice: Community dissemination of a telephone-delivered physical activity and dietary behavior change intervention. American Journal of Health Promotion, 2012:26(4):253-259.

Reeves MM, Winkler EAH, Eakin EG. The Fat and Fibre Behaviour Questionnaire:
reliability, relative validity and responsiveness to change in Australian adults with type 2 diabetes and/or hypertension. Nutrition & Dietetics, Epub ahead of print, 23 December 2014. Doi: 10.1111/1747-0080.12160.

Presentations:

Eakin EG, Oldenburg B, Del Mar C, Graves N, Reeves MM, Lawler SP, Wilkie K, Spencer AC. (23-24 November, 2006). The Logan healthy living program: A telephone delivered physical activity and diet intervention targeting patients with type 2 diabetes and hypertension. Paper presented at the 6th Annual Health and Medical Research Conference of Queensland, Brisbane, Australia.

Eakin E, Reeves M, Lawler S, Graves N, Oldenburg B, Del Mar C, Wilkie K. (7 September 2007). Short-term outcomes from the Logan Healthy Living Program: A telephone-delivered intervention for physical activity and diet in low-income patients with multiple chronic conditions. Plenary address presented at the 3rd Annual National Disease Management Conference, Melbourne, Australia.

Eakin E, Reeves M, Lawler S, Graves N, Oldenburg B, Del Mar C, Wilkie K. (13-15 October 2007). Short-term outcomes from the Logan Healthy Living Program: A telephone-delivered intervention for physical activity and diet in low-income patients with multiple chronic conditions. Awarded best paper presented at the 6th National Physical Activity Conference, Adelaide, Australia.

Eakin E, Reeves M, Lawler S, Graves N, Jordan L, Porter F. (31 January – 2 February 2008). A patient-centred approach to intervening on multiple health behaviours: Results from the Logan Healthy Living Program. Paper presented at the Australasian Society for Behavioural Health and Medicine, Sydney, Australia.

Eakin E, Reeves M, Lawler S, Porter F, Jordan L. (9-11 April 2008). Telephone-delivered, lifestyle intervention for cancer survivors recruited from primary care: short-term results of a pilot study. Paper presented at the 9th Behavioural Research in Cancer Control Conference, Melbourne, Australia.

Eakin E, Reeves M, Lawler S, Graves N, Oldenburg B, Del Mar C, Wilkie K. (27-30 August 2008). The Logan Healthy Living Program: A telephone counselling intervention for physical activity and dietary behaviour change. Paper presented at the 10th International Congress of Behavioral Medicine, Tokyo, Japan.

Porter F, Ulyate L, Reeves M, Lawler S, Winkler E, Eakin E. (4-5 September 2008). The Logan Healthy Living Program: A telephone counselling intervention for physical activity and dietary behaviour change. Paper presented at the Public Health Association of Australia – Queensland Branch, Inaugural State Research Conference, Brisbane, Australia.

Goode A, Winkler E, Owen N, Eakin E. (4-5 September 2008). A telephone-delivered intervention: relationship of calls delivered to behaviour change. Paper presented at the Public Health Association of Australia – Queensland Branch, Inaugural State Research Conference, Brisbane, Australia.

Eakin E, Reeves M, Lawler S, Graves N, Oldenburg B, Del Mar C, Wilkie K. (14-16 May 2009). The Logan Healthy Living Program: A Telephone Counselling Intervention for Physical Activity & Dietary Behaviour Change. Paper presented at the Heart Foundation Conference 2009, Brisbane, Australia.

Eakin E, Reeves M, Winkler E, Lawler S, Owen N, Graves N. (16 October 2009) Maintenance of Physical Activity & Dietary Change Following a Telephone-Delivered Intervention: The Logan Healthy Living Program. Paper presented at the 7th National Physical Activity Conference, Brisbane, Australia.

Goode A, Winkler E, Reeves M, Lawler S, Owen N, Eakin E. (16 October 2009) A Telephone-Delivered Physical Activity and Dietary Intervention: Does Intervention Dose Influence Outcomes? Paper presented at the 7th National Physical Activity Conference, Brisbane, Australia.

Waters L, Galichet B, Owen N, Eakin E. (15 October 2009) Who Participates in Physical Activity Intervention Trials? Paper presented at the 7th National Physical Activity Conference, Brisbane, Australia.

Reeves M, Marshall A, Winkler E, Owen N, Eakin E. (15 October 2009) Measuring Physical Activity Change in Broad-Reach Intervention Trials. Paper presented at the 7th National Physical Activity Conference, Brisbane, Australia.

Eakin E, Reeves M, Waters L, Fjeldsoe B, Goode A. (11 February 2010) Informing the Maintenance of Health Behaviour Change: The Logan healthy Living Program. Chair: Brian Oldenburg; Discussant: Lawrence Green. Symposium presented at Australasian Society for Behavioural Health and Medicine 7th Annual Scientific Conference, Brisbane, Australia.

Waters L, Reeves M, Fjeldsoe B, Eakin E. (10-12 February 2010). Improvements in Physical Activity Intervention Trials. Paper presented at Australasian Society for Behavioural Health and Medicine 7th Annual Scientific Conference, Brisbane, Australia.

Goode A, Owen N, Reeves M, Eakin EG. (26-28 May 2011). Translation From Research to Practice: Community Dissemination of a Telephone-Delivered Physical Activity and Dietary Behavior Change Intervention. Paper presented at the Dietitians Association of Australia - 29th National Conference, Adelaide, Australia.

Goode A, Owen N, Reeves M, Eakin EG. (15-18 June 2011). Translation From Research to Practice: Community Dissemination of a Telephone-Delivered Physical Activity and Dietary Behavior Change Intervention. Poster presented at the International Society for Behavioural Nutrition and Physical Activity Annual Meeting, Melbourne, Australia.

Goode A, Reeves M, Eakin E. (31 October – 3 November 2012). Results from the Dissemination of a Telephone-delivered intervention for healthy lifestyle and weight loss: The Optimal Health Program. Paper presented at the 4th International Congress on Physical Activity and Public Health, Sydney, Australia.
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
e.eakin@sph.uq.edu.au
Contact person for public queries
Name 10852 0
Prof 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
e.eakin@sph.uq.edu.au
Contact person for scientific queries
Name 1780 0
Prof 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
e.eakin@sph.uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary