Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000554369
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
20/04/2017
Date last updated
24/01/2020
Date data sharing statement initially provided
24/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Tailored feedback to change overweight adults’ diet and physical activity behaviours.
Scientific title
A one-year randomised controlled trial to assess the effects of a tailored intervention to improve diet and physical activity behaviours in overweight adults recruited through a social marketing campaign.
Secondary ID [1] 289963 0
Nil
Universal Trial Number (UTN)
U1111-1186-6182
Trial acronym
LL-TODAY (LiveLighter Tailored Online Diet and Activity study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight and obesity 299954 0
physical inactivity 299956 0
poor diet 302857 0
Condition category
Condition code
Diet and Nutrition 299852 299852 0 0
Obesity
Diet and Nutrition 299853 299853 0 0
Other diet and nutrition disorders
Public Health 299854 299854 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall aim of this 1-year randomised controlled trial is to investigate whether diet and physical activity behaviours can be improved with a tailored intervention in an overweight population recruited through the LiveLighter social marketing campaign in Perth, Western Australia.

Individuals who sign up to the LiveLighter website will be invited to participate in the study and if eligible will be randomised to one of three groups (200 per group):
Arm 1: tailored feedback intervention group (TF) for six months, followed by six months maintenance;
Arm 2: active control (AC) who receive no feedback on diet or physical activity behaviours but undertake the same assessments as the TF group;
Arm 3: on-line control (OC) who will complete online assessments only.

TF and AC will attend two face-to-face data collection visits at baseline, 6-months and again at one year, where they will be instructed on how to complete a 4-day mobile food record (mFR) using an investigator designed App running on a mobile device (iPhone or Android telephone) and record their physical activity for seven days by wearing an activity monitor. They will also have their height, weight and waist circumference measured. At the second face-to-face visit they will be interviewed to clarify the content of their food record and return their activity monitor. The same assessments will be repeated at six and 12 months. In addition, all groups will complete additional on-line assessments (demographic, psychosocial variables, food frequency questionnaire and physical activity behaviours) at baseline, six and 12 months. All groups will have access to the LiveLighter website materials throughout the intervention.

The intervention content for diet and physical activity will be evidence-based (for example: the Clinical guidelines for the management of overweight and obesity in Australia, the Australian Dietary Guidelines and Australia's Physical Activity and Sedentary Behaviour Guidelines). Formative focus group studies in consumers and health professionals were conducted prior to the intervention to inform the intervention features and content. The behaviour change strategies to inform the intervention will be based on the behavioural intervention technology (BIT) framework. These include self-monitoring, goal setting, motivation enhancement and feedback. Motivation enhancements (increases the likelihood of engagement) will include positive reinforcement (in the tailoring communications) and incentives.

The intervention group (TF) will be provided with a fitness tracker to monitor their daily steps for the study duration and have a mobile food record app installed on their smartphone for monitoring diet and physical activity. The intervention group (TF) will receive tailored feedback on their diet and physical activity behaviours commencing within one week of their baseline visit. Tailored dietary feedback will be based on food group analysis of 4-day mobile food record and formulated by the research dietitian. Feedback on physical activity will be from the accelerometer and fitness tracker data and formulated by the research exercise physiologist. The tailored feedback, delivered as 12 emails one week apart, will focus on key messages around their healthy eating (for example: fruits, vegetables, sugary-drinks, junk food, alcohol, portion sizes) and physical activity (for example: number of steps, sitting time, exercise intensity). Standard email templates for each topic will be developed with the dietary and physical activity feedback content personalised for each participant. The email content will be consistent with the communications for the LiveLighter campaign and will address each participants personal barriers to changing their diet and physical activity behaviours, reinforce motivation and develop skills through the meal and activity planner and healthy recipes. At 6, 12, 18 and 24 weeks intervention group participants will be prompted by the mobile food record app, to complete a 1-day food mobile record and answer daily questions on number of steps and time spent sitting in the previous day, for seven days. They will be sent re-tailored feedback, with comparison against their previous record. Other components used in tailoring will include preference for autonomy support, intention, motivation, confidence informed by self-determination theory and motivational interviewing. A process evaluation will assess to what extent the intervention reached the target audiences. A brief questionnaire will be used to evaluate the participants’ perception of the computer-tailored feedback and to comment on features they like/dislike about the program. The TF and AC groups will also provide feedback on the usability of the mobile food record app. Impact evaluation will be assessed by exit interview surveys at 14-months by telephone with the target group to assess the impact of the intervention as well as assess perceptions of the various strategies and materials.


Intervention code [1] 295652 0
Lifestyle
Intervention code [2] 295653 0
Behaviour
Intervention code [3] 295654 0
Prevention
Comparator / control treatment
Active control: face-to-face active control (AC) who receive no feedback on diet or physical activity behaviours but undertake the same assessments as the Tailored Feedback (TF) group;

Control: on-line control (OC) who will complete online assessments only.
Control group
Active

Outcomes
Primary outcome [1] 301739 0
Intake of energy-dense nutrient poor foods (sugary-drinks, junk food and alcohol serves) assessed by the 4-day mobile food record.
Timepoint [1] 301739 0
Timepoint: Baseline, and at 6 and 12 months after intervention commencement.
Primary outcome [2] 301740 0
Daily moderate/ vigorous physical activity assessed by 7-day accelerometer data.
Timepoint [2] 301740 0
Timepoint: Baseline, and at 6 and 12 months after intervention commencement.
Primary outcome [3] 301741 0
Proportion of participants that achieve a 5% reduction in body weight assessed by body weight measured by digital weighing scales.
Timepoint [3] 301741 0
Timepoint: Baseline, and at 6 and 12 months after intervention commencement.
Secondary outcome [1] 333711 0
Intake of fruit and vegetable serves assessed by the 4-day mobile food record.
Timepoint [1] 333711 0
Timepoint: 12 months after intervention commencement.
Secondary outcome [2] 333712 0
Economic evaluation assessed by ED-5D and resource use (provision of tailored feedback, mobile food record costs).
Timepoint [2] 333712 0
Timepoint: 12 months after intervention commencement
Secondary outcome [3] 333950 0
Daily sedentary activity assessed by 7-day accelerometer data.
Timepoint [3] 333950 0
Timepoint: Baseline, and at 6 and 12 months after intervention commencement.

Eligibility
Key inclusion criteria
Aged between 18-64 years
Body Mass Index between 25-40,
access to a smartphone (Android or iPhone),
readiness to participate in physical activity,
able to attend the study centre for all visits.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI > 40, BMI <25; previous obesity surgery,
serious illness or medical conditions (for example: insulin requiring diabetes, heart conditions, gastrointestinal disorders, liver disease, thyroid disease),
breastfeeding, pregnancy or planning pregnancy in the next year,
weight loss of more than 2kg of body weight in the previous 2 months,
consumption of more than 3 standard drinks of alcohol per day,
current smokers,
used a fitness tracker in the previous year,
unable to undertake physical activity
currently participating in another research study,
have an account on the LiveLighter website.
had or planning bariatric surgery in the next year,
extended absence during the study period.

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)
The study will be advertised on the LiveLighter website and participants directed to a weblink to an online screening survey. After completing the screening survey, eligible participants who consent online, will be randomised to either the control group (n=200) or invited to attend a face-to-face data collection session (n=400). A statistician, not involved in the data collection, will use a two staged, block randomisation to ensure a similar number of men and women are included in each arm of the study. This will also ensure adequate allocation concealment from the research team involved in recruitment and data collection. Allocation will be concealed by the use of sealed opaque envelopes. Once face-to-face data has been collected, a second randomisation will occur at the second face-to-face visit, with participants randomly assigned to one of two groups: 1) tailored feedback (TF) or 2) active control (AC) who receive no feedback but undertake the same assessments as the TF group. Due to the nature of the intervention, it is not possible to blind participants or researchers to their intervention group once allocation has occurred.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be conducted by a biostatistician not involved in the implementation of the trial on site (therefore not in contact with the study participants) using a randomisation table created by computer software. The electronic file will be kept in a secure password protected server by the statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome variables measured at baseline and at 1-year, will be the energy-dense nutrient-poor foods, daily moderate/vigorous physical activity and body weight / BMI. Secondary outcome variables: sedentary behaviours, serves of fruits and vegetables. The data on the change of these outcome variables in each of the two groups will be compared using analysis of covariance. Assumptions of the analyses will be assessed by examining the residuals from the analyses. Data will be transformed if the assumptions of the analyses are not satisfied. Possible covariates considered include age, gender and baseline value of the variable analysed. P-values < 0.05 will be considered as statistically significant. The effect size of the differences between treatment and control will be expressed as the adjusted mean difference and the associated 95% confidence intervals reported. The data on the change in the number of serves post intervention and follow-up time point will also be converted into binary categorical variables, greater than 0.5 serves and less than 0.5 serves. These categorical outcome variables will be analysed using multiple logistic regression and generalised estimating equations. Odds-ratio and associated 95% confidence intervals will be reported. The analyses will identify the characteristics of participants who are least likely to change their consumption of energy-dense nutrient-poor foods and physical activity identifying target groups for future health promotion.

A sample size of 600 participants (200 per group) will be required to detect a change in the primary outcome variable of at least 0.6 median serves/day of energy-dense nutrient poor (EDNP) food serves or discretionary foods (or equivalent to a 360 kJ/day reduction) between groups at 90% power and 5% level of significance. Based on our previous data, the distributions of EDNP food serves are expected to be skewed and hence a non-parametric adjustment to the sample size calculation using the Mann-Whitney test was used. Assuming a drop-out rate of about 20%, a total of 600 subjects will be recruited with equal numbers of males and females.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2017
Actual
17/08/2017
Date of last participant enrolment
Anticipated
15/12/2017
Actual
13/07/2018
Date of last data collection
Anticipated
21/12/2018
Actual
16/09/2019
Sample size
Target
600
Accrual to date
Final
286
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 296175 0
Government body
Name [1] 296175 0
Healthway Health Promotion Research Grant
Country [1] 296175 0
Australia
Funding source category [2] 304781 0
Government body
Name [2] 304781 0
East Metropolitan Health Service
Country [2] 304781 0
Australia
Primary sponsor type
Individual
Name
Deborah Kerr
Address
School of Public Health,
Curtin University,
GPO Box U1987,
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 295084 0
None
Name [1] 295084 0
Address [1] 295084 0
Country [1] 295084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297421 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 297421 0
Ethics committee country [1] 297421 0
Australia
Date submitted for ethics approval [1] 297421 0
Approval date [1] 297421 0
06/04/2016
Ethics approval number [1] 297421 0
HR61/2016

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

Contacts
Principal investigator
Name 68358 0
Prof Deborah Kerr
Address 68358 0
School of Public Health,
Curtin University,
GPO Box U1987,
Perth WA 6845
Country 68358 0
Australia
Phone 68358 0
+61 892664122
Fax 68358 0
+618 92662958
Email 68358 0
[email protected]
Contact person for public queries
Name 68359 0
Deborah Kerr
Address 68359 0
School of Public Health,
Curtin University,
GPO Box U1987,
Perth WA 6845
Country 68359 0
Australia
Phone 68359 0
+61 892664122
Fax 68359 0
+618 92662958
Email 68359 0
[email protected]
Contact person for scientific queries
Name 68360 0
Deborah Kerr
Address 68360 0
School of Public Health,
Curtin University,
GPO Box U1987,
Perth WA 6845
Country 68360 0
Australia
Phone 68360 0
+61 892664122
Fax 68360 0
+618 92662958
Email 68360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 12 months and ending 5 years following main results publication
Available to whom?
bona fide research groups with a qualified statistician
Available for what types of analyses?
only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator. Data will be made available by emailing the Principal Investigator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6594Study protocolHalse, R. E., C. L. Shoneye, C. M. Pollard, J. Jancey, J. A. Scott, I. S. Pratt, S. S. Dhaliwal, R. Norman, L. M. Straker, C. J. Boushey, E. J. Delp, F. Zhu, A. J. Harray, M. A. Szybiak, A. Finch, J. A. McVeigh, B. Mullan, C. E. Collins, S. A. Mukhtar, K. N. Edwards, J. D. Healy, and D. A. Kerr. 2019. 'Improving Nutrition and Activity Behaviors Using Digital Technology and Tailored Feedback: Protocol for the LiveLighter Tailored Diet and Activity (ToDAy) Randomized Controlled Trial', JMIR Res Protoc, 8: e12782.  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDemographic and psychosocial correlates of measurement error and reactivity bias in a 4-d image-based mobile food record among adults with overweight and obesity.2023https://dx.doi.org/10.1017/S0007114522001532
N.B. These documents automatically identified may not have been verified by the study sponsor.