Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000803796
Ethics application status
Approved
Date submitted
24/05/2022
Date registered
8/06/2022
Date last updated
25/08/2024
Date data sharing statement initially provided
8/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of technology-assisted dietetic counselling on diet quality of adults living with obesity
Scientific title
The effect of technology-assisted dietetic counselling on diet quality of adults living with obesity: A randomised controlled trial to build effective dietetic service delivery in a primary health care setting
Secondary ID [1] 306788 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 325837 0
Condition category
Condition code
Diet and Nutrition 323163 323163 0 0
Obesity
Diet and Nutrition 323164 323164 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design: A randomised controlled trial, comparing intervention with control is the most appropriate design to identify the cost-effectiveness of the intervention. Using dietitians to deliver the intervention will assist in future workforce and resource allocation. Consenting patients will be randomised (1:1) to Intervention or Control. Assessments will occur at 0, 6 and 12 months.

Why: The high and increasing prevalence of obesity in Australia is a major challenge for health care delivery and substantially burdens the health sector. The effects of obesity are widely recognised as one of Australia's leading health concerns, affecting all age and socioeconomic groups.

What (materials): Participants will be provided with access to the mFR application on their mobile device to record their dietary intake at 0, 6 and 12 months. They will be asked to take “Before eating” and “after eating” images of all foods and beverages consumed over four consecutive days. This activity is expected to take approximately 10 minutes for recording days. Images are automatically uploaded to a secure cloud server via Wi-Fi or 4G/5G network. Feedback will be formulated from analysis of the 4-day mFR and will be included in the video consultations for the intervention group. Study research dietitians who will undertake the consultations will be provided with training and a dietetic consultation guide for each session. The consultation guide will cover using the study systems, mFR application, technology use, conducting video consultations and behaviour change theory. Both intervention and control groups will be provided information from the Australian Dietary Guidelines website “tips for losing weight healthily”. This information will be provided as a hard copy booklet after randomisation.

What (procedures):
Research dietitians: will undertake 8 hours of training, prior to undertaking consultations with participants. The training will include approximately two hours of self-paced recorded online training in the dietitian’s own time and six hours of group workshops to be delivered online or in person. The training will include current evidence-based practice for people living with obesity, addressing weight bias and stigma, study design, ethics, behaviour change theory, style of communication, use of technology and study systems, documentation, fidelity of implementation adherence.

Participants: will be recruited by letters sent to individuals randomly selected from the electoral roll in Perth in the East Metropolitan Health Service district, to provide representation across socio-economic status. Another recruitment method will supplement the mail out and focus on gaining the support of GP’s, using recruitment postcards and posters distributed through GP practices and Primary Health Networks within the same post codes selected for the electoral roll mail out. Quota sampling will ensure equal numbers between study groups and gender. After receiving the letter of invitation, those who wished to take part in the study will contact the research team by email, mobile telephone (text or voice), or the study website where they will be screened for eligibility by completing a web form. Eligible participants will be notified via email and invited to attend two face-to-face visits one week apart (n=430) with the first at their closest location (Curtin University or teaching hospital), where they will discuss and sign the informed consent document. At the baseline visit, participants will receive training in the use of the 4-day mobile food record (mFR), undergo a blood test, DXA whole body scan and anthropometry. The assessments will be repeated for both intervention and control again at 6 and 12 months.

Who will deliver the intervention:
Research dietitians with tertiary dietetic qualifications and an Accredited Practising Dietitian (APD) with Dietitians Australia. Additional skills required will be experience in counselling in weight management, a demonstrated understanding of participants living with obesity, including weight bias and stigma, social and environmental influences, food insecurity and access to health care.
General Practitioners with the appropriate qualifications to practice general medicine in Australia will provide usual care. GPs will be notified by mail that their patient has volunteered and provided with information about the trial, blood test results and contact details of the research team. Patients will be encouraged to discuss their involvement with their GP. A register of response rate and recruitment source will inform future recruitment pathways.

Mode of delivery, duration, intensity, dose: Participants will be offered video consultations (approximately 15 to 30 minutes based on intervention stage) with a dietitian for the first six months (at 2, 4, 8, 12, 16, 24 weeks) to provide support and guidance for unhelpful behaviours (e.g., emotional eating) and additional maintenance calls (relapse prevention) at 9 and 12 months (8 in total). The consultation will cover dietary feedback focusing on their diet quality score, goal setting and behavioural strategies. Participants will be provided with a text message summary and a short report on their diet quality score delivered via email. With permission of the patient, a dietary report will be sent to their GP. Feedback will be formulated from analysis of the 4-day mFR and will focus on key dietary messages. The content will address each participant’s personal barriers to changing dietary behaviours, capability, reinforce motivation, and guide adoption of health-enhancing habits.

Intervention features: The selection of intervention features and strategies will be guided by the capability, opportunity, motivation, and behaviour (COM-B) model. The COM-B model identifies behavioural targets when developing interventions and focuses on three factors required to change behaviour: capability, opportunity, and motivation. Intervention features and content and behaviour changes techniques will include: 1) Behavioural: Self-monitoring of dietary intake and body weight, tailored feedback on dietary behaviours, barrier identification, problem solving, goal setting, motivation enhancement, feedback to increase likelihood of engagement, relapse prevention. 2) Tailoring strategies and style of communication: Autonomous supportive style of communication informed by self-determination theory and motivational interviewing for dietitian consultations and all communications. 3) Nutrition - Improving diet quality score, eating less at meals or snacks (except for salad and vegetables), eating less often (less snacking, except for salad and vegetables).

Location: The trial will be undertaken in study participants residing in Perth, Western Australia in the East Metropolitan Health Service District (EMHS). Individuals will be randomly selected from the electoral roll in the EMHS district, to provide representation across socio-economic status.

Adherence: Fidelity of implementation adherence will be guided by a conceptual framework for implementation fidelity (adherence to the guide as prescribed, quality of delivery) and will be assessed for dietitians using measures of fidelity and engagement.

Process evaluation: The UK Medical Research Council process evaluation framework will guide and evaluate the implementation and impact of the intervention and measure fidelity, dose and reach. From our own work, additional components relevant for digital interventions will assess acceptability, engagement, effectiveness and sustainability. A questionnaire will evaluate participants’ perception of the intervention (i.e., dietetic video consults, feedback, usefulness of advice, suitability, and relevance to age group). Approximately 20 participant exit interview surveys will be conducted via telephone at 14 months to assess intervention impact, perceptions of various strategies and materials from selected program completers and non-completers. Exit interviews will also be conducted with dietitians who undertook the consultations. Discussions will be audio-recorded and transcribed verbatim for efficacy and accuracy by a professional transcription service. Transcripts will be managed using NVivo software.

Economic Evaluation: A stepped economic evaluation will consider the relative costs and outcomes of the intervention. For the final step, to facilitate a cost-utility analysis, the EuroQol-5D will be administered to capture quality of life. Quality-adjusted life years will be estimated for both groups. For costs, collating the time needed to provide tailored advice, medication, supplement use, and self-estimated weekly food expenditure will allow economic evaluation from the perspective of the health system and the broader society (by considering all costs).

Intervention code [1] 323243 0
Treatment: Other
Intervention code [2] 323244 0
Behaviour
Intervention code [3] 323245 0
Lifestyle
Comparator / control treatment
Active - control group will receive usual care from their GP (6-monthly monitoring) and complete all measures as per the intervention group. Additional instructions will be emailed or mailed to control group participants on collection of measures (e.g., mobile food record, blood test) at 6 and 12 months prior to their face-to-face visit. The control group will be provided with ‘standard care’ using information from the Australian Dietary Guidelines website “tips for losing weight healthily”. This information will be provided as a hard copy booklet after randomisation. At the end of the study, they will be emailed a personalized report on their outcomes, including their dietary feedback report.
Control group
Active

Outcomes
Primary outcome [1] 330912 0
Change in body weight assessed by body weight measured by digital weighing scales
Timepoint [1] 330912 0
Baseline, and at 6 and 12 months (primary endpoint) after intervention commencement
Primary outcome [2] 330913 0
Change in diet quality score as derived from 4-day dietary record
Timepoint [2] 330913 0
Baseline, and at 6 and 12 months (primary endpoint) after intervention commencement
Secondary outcome [1] 408046 0
Changes in percentage body fat as measured by whole body DXA scan
Timepoint [1] 408046 0
Baseline, and at 6 and 12 months after intervention commencement.
Secondary outcome [2] 408047 0
Changes in total cholesterol, triglyceride, LDL/HDL cholesterol, fasting glucose and glycated Hb as measured by blood tests.
Timepoint [2] 408047 0
Baseline, and at 6 and 12 months after intervention commencement
Secondary outcome [3] 408048 0
Economic evaluation - stepped cost-effectiveness analysis of the relative costs and outcomes of the intervention assessed by the EuroQol-5D to capture quality of life
Timepoint [3] 408048 0
Baseline, and at 6 and 12 months after intervention commencement
Secondary outcome [4] 408049 0
Impact of intervention (fidelity, dose and reach) as assessed by the UK Medical Research Council evaluation framework
Timepoint [4] 408049 0
Baseline, and at 6 and 12 months after intervention commencement

Eligibility
Key inclusion criteria
Body Mass Index great than or equal to 30 and less than or equal to 45 kg/m2
access to a mobile telephone with internet access,
able to attend the study centre for all visits,
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
medical dietary restrictions (e.g. low potassium for renal failure),
Diabetes requiring insulin,
Severe heart conditions (e.g. cardiac failure requiring fluid restriction, a stroke or myocardial infarction in the previous 6 months),
Severe life limiting illness receiving palliative treatment (e.g. cancer, cirrhosis, pulmonary disease or heart failure),
Pregnancy or breastfeeding, or planning to breastfeed or become pregnant in the next year,
Receiving treatment for an eating disorder,
Receiving counselling from a dietitian,
Had or planned to have surgical intervention for weight management in the next year.
Unable to participate in telehealth dietary consultations
Taking or plan to take weight loss medications (e.g. orlistat, Liraglutide, GLP-1, SGT-2) in the next 12 months.

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)
Allocation was concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used with allocation concealment from the active research team via the use of sealed opaque envelopes. The randomisation will be in blocks of four, with stratification by sex where participants will be assigned to either Intervention or Standard Care Control (1:1). Sequence generation will be conducted prior to the commencement of the study by a biostatistician using a randomisation table created in Stata.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: power calculations are based on a sample size sufficient to assess if the difference between the two groups is clinically significant. A sample size of 342 participants (n=171 per group) will have sufficient power to detect a change in the primary outcome variable of at least a 5% difference in body weight at 12-months between groups, using a conservative estimate of standard deviation, at 90% power and 5% level of significance. Assuming a drop-out rate of 20%, a total of 430 (215 in each group) participants will be recruited. Estimates of means and standard deviations, including percentage dropout, were obtained from existing trial data for the power calculation for this study.
Statistical analysis: The following primary outcome variable change in weight and change in diet quality score. Secondary outcome variables include changes, total cholesterol, triglyceride, LDL/HDL cholesterol, fasting glucose and glycated Hb. Outcomes will identify characteristics of responders who remained engaged and reported improvements in key behaviours and quantify resource use associated with each arm of the study, to be used in an economic evaluation of the intervention. Data on change in outcome variables in each of the two groups will be compared using general linear models after adjusting for covariates. Possible covariates will include age, sex, country of birth, ethnicity, highest education level, socioeconomic index for area, and baseline value of the variable analysed. P-values < .05 will be considered statistically significant. Effect size of differences between groups will be expressed as adjusted mean difference and associated 95% CIs. Data on change in outcome variables post-intervention and follow-up time points will also be converted into binary categorical variables and analysed using multivariable logistic regression and generalized estimating equations. Odds ratio and associated 95% CIs will be reported. The analyses will identify characteristics of participants who are more likely to change their weight.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/04/2023
Actual
6/07/2023
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
430
Accrual to date
279
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25565 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 25566 0
Bentley Health Service - Bentley
Recruitment hospital [3] 25567 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment postcode(s) [1] 37594 0
6003 - Highgate
Recruitment postcode(s) [2] 37595 0
6004 - East Perth
Recruitment postcode(s) [3] 37596 0
6050 - Menora
Recruitment postcode(s) [4] 37597 0
6052 - Inglewood
Recruitment postcode(s) [5] 37598 0
6053 - Bayswater
Recruitment postcode(s) [6] 37599 0
6054 - Bassendean
Recruitment postcode(s) [7] 37600 0
6055 - Guildford
Recruitment postcode(s) [8] 37601 0
6056 - Midland
Recruitment postcode(s) [9] 37602 0
6057 - Maida Vale
Recruitment postcode(s) [10] 37603 0
6058 - Forrestfield
Recruitment postcode(s) [11] 37604 0
6062 - Morley
Recruitment postcode(s) [12] 37605 0
6063 - Beechboro
Recruitment postcode(s) [13] 37606 0
6070 - Darlington
Recruitment postcode(s) [14] 37607 0
6071 - Glen Forrest
Recruitment postcode(s) [15] 37608 0
6072 - Mahogany Creek
Recruitment postcode(s) [16] 37609 0
6076 - Bickley
Recruitment postcode(s) [17] 37610 0
6100 - Victoria Park
Recruitment postcode(s) [18] 37611 0
6101 - Carlisle
Recruitment postcode(s) [19] 37612 0
6102 - Bentley
Recruitment postcode(s) [20] 37613 0
6103 - Rivervale
Recruitment postcode(s) [21] 37614 0
6104 - Belmont
Recruitment postcode(s) [22] 37615 0
6105 - Cloverdale
Recruitment postcode(s) [23] 37616 0
6107 - Beckenham
Recruitment postcode(s) [24] 37617 0
6108 - Thornlie
Recruitment postcode(s) [25] 37618 0
6109 - Maddington
Recruitment postcode(s) [26] 37619 0
6110 - Gosnells
Recruitment postcode(s) [27] 37620 0
6111 - Kelmscott
Recruitment postcode(s) [28] 37621 0
6112 - Armadale
Recruitment postcode(s) [29] 37622 0
6147 - Lynwood
Recruitment postcode(s) [30] 37623 0
6151 - Kensington
Recruitment postcode(s) [31] 41388 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 311125 0
Government body
Name [1] 311125 0
Australian Government
Country [1] 311125 0
Australia
Primary sponsor type
Individual
Name
Deborah Kerr
Address
Curtin School of Population Health, Curtin University,
GPO Box U1987, Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 312463 0
None
Name [1] 312463 0
Address [1] 312463 0
Country [1] 312463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310655 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 310655 0
Ethics committee country [1] 310655 0
Australia
Date submitted for ethics approval [1] 310655 0
07/12/2021
Approval date [1] 310655 0
07/02/2022
Ethics approval number [1] 310655 0
HRE2022-0059
Ethics committee name [2] 313860 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [2] 313860 0
Ethics committee country [2] 313860 0
Australia
Date submitted for ethics approval [2] 313860 0
29/07/2022
Approval date [2] 313860 0
30/08/2022
Ethics approval number [2] 313860 0
RGS0000005490

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

Contacts
Principal investigator
Name 118410 0
Prof Deborah Kerr
Address 118410 0
Curtin School of Population Health,
Curtin University
GPO Box U1987, Perth, WA, 6845.
Country 118410 0
Australia
Phone 118410 0
+61 892664122
Fax 118410 0
+61 892662958
Email 118410 0
[email protected]
Contact person for public queries
Name 118411 0
Deborah Kerr
Address 118411 0
Curtin School of Population Health,
Curtin University
GPO Box U1987, Perth, WA, 6845.
Country 118411 0
Australia
Phone 118411 0
+61 892664122
Fax 118411 0
+61 892662958
Email 118411 0
[email protected]
Contact person for scientific queries
Name 118412 0
Deborah Kerr
Address 118412 0
Curtin School of Population Health,
Curtin University
GPO Box U1987, Perth, WA, 6845.
Country 118412 0
Australia
Phone 118412 0
+61 892664122
Fax 118412 0
+61 892662958
Email 118412 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?

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.