Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Adult use of a telephone coaching service following receipt of telephone, email or posted service information versus no information.
Query!
Secondary ID [1]
253370
0
There are no secondary ids for this trial
Query!
Universal Trial Number (UTN)
U1111-1118-9309
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
overweight and obesity
260906
0
Query!
fruit and vegetable consumption
260907
0
Query!
physical activity
260908
0
Query!
Condition category
Condition code
Diet and Nutrition
259044
259044
0
0
Query!
Obesity
Query!
Public Health
259045
259045
0
0
Query!
Health service research
Query!
Public Health
259046
259046
0
0
Query!
Health promotion/education
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
257808
0
Prevention
Query!
Comparator / control treatment
4. No information about the telephone coaching services provided in any format (mailed, emailed or via telephone) by the researchers
Query!
Control group
Active
Query!
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
Query!
Assessment method [1]
259894
0
Query!
Timepoint [1]
259894
0
Baseline and 3 months post baseline data collection
Query!
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
Query!
Assessment method [2]
259895
0
Query!
Timepoint [2]
259895
0
Baseline and 3 months post baseline data collection
Query!
Secondary outcome [1]
268781
0
Self reported fruit and vegetable consumption. This will be assessed using two items from the NSW Population Health Survey
Query!
Assessment method [1]
268781
0
Query!
Timepoint [1]
268781
0
Baseline and 3 months post baseline data collection
Query!
Secondary outcome [2]
268782
0
Self reported physical activity. This will be assessed using items of the Active Australia survey
Query!
Assessment method [2]
268782
0
Query!
Timepoint [2]
268782
0
Baseline and 3 months post baseline data collection
Query!
Secondary outcome [3]
268783
0
Body Mass Index z-score. This will be assessed using two items from the NSW Population Health Survey
Query!
Assessment method [3]
268783
0
Query!
Timepoint [3]
268783
0
Baseline and 3 months post baseline data collection
Query!
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
Query!
Assessment method [4]
268868
0
Query!
Timepoint [4]
268868
0
Baseline and 3 months post baseline data collection
Query!
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
Query!
Assessment method [5]
268869
0
Query!
Timepoint [5]
268869
0
Baseline and 3 months post baseline data collection
Query!
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
Query!
Assessment method [6]
268870
0
Query!
Timepoint [6]
268870
0
Baseline and 3 months post baseline data collection
Query!
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
Query!
Assessment method [7]
268871
0
Query!
Timepoint [7]
268871
0
Baseline and 3 months post baseline data collection
Query!
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).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Participants who can not understand written and spoken english.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
18/01/2011
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
800
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
258285
0
University
Query!
Name [1]
258285
0
The University of Newcastle
Query!
Address [1]
258285
0
University Dr, Callaghan, NSW, 2308
Query!
Country [1]
258285
0
Australia
Query!
Funding source category [2]
258286
0
Government body
Query!
Name [2]
258286
0
Hunter New England Population Health
Query!
Address [2]
258286
0
Longworth Ave, Wallsend, NSW, 2287
Query!
Country [2]
258286
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Luke Wolfenden
Query!
Address
C/O Hunter New England Population Health, Locked Bag 10, Wallsend, NSW, 2287
Query!
Country
Australia
Query!
Secondary sponsor category [1]
257449
0
None
Query!
Name [1]
257449
0
Query!
Address [1]
257449
0
Query!
Country [1]
257449
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260272
0
Hunter New England Human Research Ethics Committee
Query!
Ethics committee address [1]
260272
0
Hunter New England Human Research Ethics Committee
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Query!
Ethics committee country [1]
260272
0
Australia
Query!
Date submitted for ethics approval [1]
260272
0
Query!
Approval date [1]
260272
0
04/09/2009
Query!
Ethics approval number [1]
260272
0
09/06/17/4.03
Query!
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.
Query!
Trial website
Nil
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32065
0
Query!
Address
32065
0
Query!
Country
32065
0
Query!
Phone
32065
0
Query!
Fax
32065
0
Query!
Email
32065
0
Query!
Contact person for public queries
Name
15312
0
Luke Wolfenden
Query!
Address
15312
0
C/O Hunter New England Population Health
Locked Bag 10, Wallsend, NSW, 2287
Query!
Country
15312
0
Australia
Query!
Phone
15312
0
+61 2 49246567
Query!
Fax
15312
0
Query!
Email
15312
0
[email protected]
Query!
Contact person for scientific queries
Name
6240
0
Luke Wolfenden
Query!
Address
6240
0
C/O Hunter New England Population Health
Locked Bag 10, Wallsend, NSW, 2287
Query!
Country
6240
0
Australia
Query!
Phone
6240
0
+61 2 49246567
Query!
Fax
6240
0
Query!
Email
6240
0
[email protected]
Query!
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.
Download to PDF