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Trial registered on ANZCTR


Registration number
ACTRN12611000059965
Ethics application status
Approved
Date submitted
9/01/2011
Date registered
17/01/2011
Date last updated
31/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of strategies to encourage use of a free public telephone coaching service for weight loss, healthy eating and physical activity
Scientific title
Adult use of a telephone coaching service following receipt of telephone, email or posted service information versus no information.
Secondary ID [1] 253370 0
There are no secondary ids for this trial
Universal Trial Number (UTN)
U1111-1118-9309
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight and obesity 260906 0
fruit and vegetable consumption 260907 0
physical activity 260908 0
Condition category
Condition code
Diet and Nutrition 259044 259044 0 0
Obesity
Public Health 259045 259045 0 0
Health service research
Public Health 259046 259046 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 3 month trial consists of 2 intervention groups 1 A printed brochure providing information about a free healthy eating, physical activity or weight loss telephone coaching service mailed to participants once. 2. A electronic brochure providing information about a free healthy eating, physical activity or weight loss telephone coaching service e-mailed to participants once. It is not compulsory for participants in each group to read or attend to information provided in each format (mail, or email)or to contact the coaching service. The use of materials and the telephone coaching service will be at the discretion of participants
Intervention code [1] 257808 0
Prevention
Comparator / control treatment
4. No information about the telephone coaching services provided in any format (mailed, emailed or via telephone) by the researchers
Control group
Active

Outcomes
Primary outcome [1] 259894 0
% or participants per group receiving one or more support calls from the telephone coaching service over the 3 months since baseline. The measure will be assessed via participant self report
Timepoint [1] 259894 0
Baseline and 3 months post baseline data collection
Primary outcome [2] 259895 0
Mean number of telephone coaching contacts received by participants per group over the 3 months since baseline. The will be assessed via participant self report
Timepoint [2] 259895 0
Baseline and 3 months post baseline data collection
Secondary outcome [1] 268781 0
Self reported fruit and vegetable consumption. This will be assessed using two items from the NSW Population Health Survey
Timepoint [1] 268781 0
Baseline and 3 months post baseline data collection
Secondary outcome [2] 268782 0
Self reported physical activity. This will be assessed using items of the Active Australia survey
Timepoint [2] 268782 0
Baseline and 3 months post baseline data collection
Secondary outcome [3] 268783 0
Body Mass Index z-score. This will be assessed using two items from the NSW Population Health Survey
Timepoint [3] 268783 0
Baseline and 3 months post baseline data collection
Secondary outcome [4] 268868 0
Frequency (per week) participants usually eat confectionary. This will be assessed using an item from the NSW Population Health Survey
Timepoint [4] 268868 0
Baseline and 3 months post baseline data collection
Secondary outcome [5] 268869 0
Frequency (per week) participants usually have takeaway meals or snacks. This will be assessed using an item from the NSW Population Health Survey
Timepoint [5] 268869 0
Baseline and 3 months post baseline data collection
Secondary outcome [6] 268870 0
Frequency (per week) participants usually eat potato crisps or other salty snacks. This will be assessed using an item from the NSW Population Health Survey
Timepoint [6] 268870 0
Baseline and 3 months post baseline data collection
Secondary outcome [7] 268871 0
The number of cups of soft drink, cordials or sports drinks participants usually drink in a day? This will be assessed using an item from the NSW Population Health Survey
Timepoint [7] 268871 0
Baseline and 3 months post baseline data collection

Eligibility
Key inclusion criteria
Participants of a community research cohort with a self reported BMI of >25, or consuming fewer then 2 serves of fruit or 5 serves of vegetables per day (assessed using items from the NSW Health Survey), or engaging in insufficient levels of physical activity (assessed using the active australia survey).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who can not understand written and spoken english.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who had previously participated in a random telephone household health survey and agreed to be part of a research cohort will be telephoned by a research assistant and invited to participate in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of the 4 groups in a ratio of 1:1:1:1 using a simple randomization procedure performed by a computerized program during the telephone interview.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 258285 0
University
Name [1] 258285 0
The University of Newcastle
Address [1] 258285 0
University Dr, Callaghan, NSW, 2308
Country [1] 258285 0
Australia
Funding source category [2] 258286 0
Government body
Name [2] 258286 0
Hunter New England Population Health
Address [2] 258286 0
Longworth Ave, Wallsend, NSW, 2287
Country [2] 258286 0
Australia
Primary sponsor type
Individual
Name
Luke Wolfenden
Address
C/O Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287
Country
Australia
Secondary sponsor category [1] 257449 0
None
Name [1] 257449 0
Address [1] 257449 0
Country [1] 257449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260272 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 260272 0
Hunter New England Human Research Ethics Committee
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 260272 0
Australia
Date submitted for ethics approval [1] 260272 0
Approval date [1] 260272 0
04/09/2009
Ethics approval number [1] 260272 0
09/06/17/4.03

Summary
Brief summary
The study seeks to test the efficacy of a variety of strategies to encourage the use of a telephone coaching service to encourage healthy eating, physical activity and weight loss among adults in the community. It is hypothesized that telephone, emailed and mailed information about the service will be more effective then no information about the service. The use of the telephone service as well as any changes in physical activity, healthy eating or weight status will be assessed by telephone interview 3 months following baseline data collection.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32065 0
Address 32065 0
Country 32065 0
Phone 32065 0
Fax 32065 0
Email 32065 0
Contact person for public queries
Name 15312 0
Luke Wolfenden
Address 15312 0
C/O Hunter New England Population Health
Locked Bag 10, Wallsend, NSW, 2287
Country 15312 0
Australia
Phone 15312 0
+61 2 49246567
Fax 15312 0
Email 15312 0
luke.wolfenden@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 6240 0
Luke Wolfenden
Address 6240 0
C/O Hunter New England Population Health
Locked Bag 10, Wallsend, NSW, 2287
Country 6240 0
Australia
Phone 6240 0
+61 2 49246567
Fax 6240 0
Email 6240 0
luke.wolfenden@hnehealth.nsw.gov.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