Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000114549
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
10/02/2015
Date last updated
23/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Do Making Habits or Breaking Habits Influence Weight Loss and Weight Loss Maintenance: A Randomised Controlled Trial
Scientific title
Overweight or obese adults, participating in a 12-week habit-based intervention (Ten Top Tips or Do Something Different) or wait list to achieve weight loss maintenance 12-months after the intervention.
Secondary ID [1] 286001 0
Nil
Universal Trial Number (UTN)
U1111-1166-3131
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293963 0
Overweight 293964 0
Condition category
Condition code
Diet and Nutrition 294261 294261 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: '10 Top Tips' aims to increase habitual performance of healthy lifestyle behaviours such as 'Keep a food diary', 'Switch to low fat food', 'Practice portion control' etc. The tips are provided to the participants in the form of a single pamphlet which is provided at baseline. A tracking diary is also provided for record keeping. The intervention period is 12 weeks.

Intervention 2: 'Do Something Different' aims to break daily habits and increase behavioural flexibility by assigning participants a different task to perform each day. Examples of these tasks include: 'Take a different route to work', 'Write a short story', 'Wear something you've never worn before' etc. These tasks are emailed or text messaged to the participants depending on their preference. Adherence is not monitored. The intervention period is 9 weeks.

No intervention group will receive both interventions. Both interventions explained above will be administered by the principle researcher of this study who is a qualified dietitian.
Intervention code [1] 290979 0
Lifestyle
Intervention code [2] 290980 0
Behaviour
Intervention code [3] 291042 0
Treatment: Other
Comparator / control treatment
Waitlist group will be be given a choice to commence one of the interventions after a 12 week wait.
Control group
Active

Outcomes
Primary outcome [1] 294058 0
Weight loss maintenance in kilograms at 12-months from post-intervention. This outcome will be assessed by the researcher weighing the participants 12 months post intervention using a calibrated seca scale.
Timepoint [1] 294058 0
12 months post intervention completion
Secondary outcome [1] 312433 0
Waist circumference measured in centimetres with a tape measure.
Timepoint [1] 312433 0
12 months post intervention completion
Secondary outcome [2] 312598 0
Wellbeing was measured using a validated tool called "Do Something Different Diagnostics"
Timepoint [2] 312598 0
12 months post intervention completion
Secondary outcome [3] 333055 0
Proportion of participants achieving 5% total body weight loss which will be assessed by the researchers weighing participants using a calibrated seca scale.
Timepoint [3] 333055 0
12-month follow-up from post-intervention
Secondary outcome [4] 333056 0
Anxiety was measured using the validated tool called "Do Something Different Diagnostics"
Timepoint [4] 333056 0
12 months post-intervention
Secondary outcome [5] 333057 0
Depression was measured using the validated tool called "Do Something Different Diagnostics"
Timepoint [5] 333057 0
12 months post intervention
Secondary outcome [6] 333058 0
Habits were measured using the validated tool called "Do Something Different Diagnostics"
Timepoint [6] 333058 0
12 months post-intervention
Secondary outcome [7] 333059 0
Behaviours were measured using the validated tool called "Do Something Different Diagnostics"
Timepoint [7] 333059 0
12 months post-intervention

Eligibility
Key inclusion criteria
Obese or overweight by BMI classification (equal or greater than 25.0kg/m2)
Able to consent for themselves
Able to speak English
Live on the Gold Coast, QLD
Able to access their email and/or phone every day
Able to exercise
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participating in other weight management programs or taking any medications which affect appetite, metabolism or weight
Pregnant
Unable to provide consent due to mental incapacity
Significantly ill
220kg or over

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)
We will identify potential participants via a local televised news segment as well as local ABC radio interview. Participants will be initially screened on the telephone for eligibility. All participants will be require to attend an initial interview in order to provide informed consent and be formally recruited in to the study.

Eligible participants will be enrolled into the study. Non eligible participants will be informed of so and recommended to see their general practitioner for weight management advice and further referral to a dietitian or appropriate weight loss program.

Randomisation:
Computer generated randomisation will occurred once eligible participants have attended the initial baseline appointment. We will use minimisation stratified on BMI categories (overweight, obese class I, II, III), age categories (18-32, 33-47, 48-62, 63-75 years); and gender. After randomisation, participants in the active intervention groups (Ten Top Tips and Do Something Different) will attend a group meeting for their intervention with the primary researcher to commence the program. Participants randomised to the wait list group will be offered either the DSD or TTT intervention after waiting 12 weeks.

Allocation concealment will be achieved as each participant will be coded upon recruitment and their individual data (BMI, age, gender) will be entered into a minimsation software (MINIM). MINIM will automatically generate the intervention allocation. This information will only be available to the 4 researchers working on this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We used minimization stratified on BMI categories (overweight, obese class I, II, III), age categories (18-32, 33-47, 48-62, 63-75 years); and gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2015
Actual
26/06/2015
Date of last participant enrolment
Anticipated
Actual
16/10/2015
Date of last data collection
Anticipated
Actual
9/12/2016
Sample size
Target
75
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290602 0
University
Name [1] 290602 0
Bond University
Country [1] 290602 0
Australia
Primary sponsor type
Individual
Name
Gina Cleo
Address
Bond University
14 University Dr, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 289289 0
Individual
Name [1] 289289 0
Roger Hughes
Address [1] 289289 0
Bond University
14 University Dr, Robina QLD 4226
Country [1] 289289 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292236 0
Bond University Research Ethics Committee
Ethics committee address [1] 292236 0
Ethics committee country [1] 292236 0
Australia
Date submitted for ethics approval [1] 292236 0
26/01/2015
Approval date [1] 292236 0
17/02/2015
Ethics approval number [1] 292236 0
RO1888B

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

Contacts
Principal investigator
Name 54214 0
Miss Gina Cleo
Address 54214 0
Center for Research in Evidence Based Practice, 14 University Drive, Robina, QUEENSLAND, AUSTRALIA 4226
Country 54214 0
Australia
Phone 54214 0
+61432688101
Fax 54214 0
Email 54214 0
[email protected]
Contact person for public queries
Name 54215 0
Gina Cleo
Address 54215 0
Center for Research in Evidence Based Practice, 14 University Drive, Robina, QUEENSLAND, AUSTRALIA 4226
Country 54215 0
Australia
Phone 54215 0
+61432688101
Fax 54215 0
Email 54215 0
[email protected]
Contact person for scientific queries
Name 54216 0
Gina Cleo
Address 54216 0
Center for Research in Evidence Based Practice, 14 University Drive, Robina, QUEENSLAND, AUSTRALIA 4226
Country 54216 0
Australia
Phone 54216 0
+61432688101
Fax 54216 0
Email 54216 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
SourceTitleYear of PublicationDOI
EmbaseParticipant experiences of two successful habit-based weight-loss interventions in Australia: A qualitative study.2018https://dx.doi.org/10.1136/bmjopen-2017-020146
N.B. These documents automatically identified may not have been verified by the study sponsor.