The effect of technology-assisted dietetic counselling on diet quality of adults living with obesity

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).