Lifestyle clinical trial for weight loss in adults living with multiple sclerosis (MS).

The intervention will focus on an interdisciplinary model of care which has previously been shown to be effective in managing weight. The innovation is that the client interface involves consultation with a single healthcare professional who has been trained in the diet, exercise and psychology intervention. Participants allocated to the intervention arm will, therefore, receive tailored dietary and physical activity advice aligned with the current evidence for MS management [Wills et al, Mult Scler Relat Disord. 2024;92:105949]. The intervention group will receive this advice from the single healthcare professional at weeks 2, 4, 6, 8, 16 and 20 of the intervention period, for 1-hour at each timepoint. Adherence will be monitored via food and exercise diaries. The dietetic element of the trial will be the provision of tailored dietary advice that is personalised to the needs of the participant. This will be based on an initial assessment of dietary intake at baseline and the energy requirements, sex and activity level of the participant. The participant will work with their healthcare professional to set their own SMART goals. From the dietary perspective, this goal will focus on monitoring adherence to the Australian Dietary Guidelines [National Health and Medical Research Council, 2013. Australian Dietary Guidelines Summary, Canberra]. These guidelines encourage a variety of nutritious foods from the five food groups (vegetables, fruit, grain foods, lean meats/alternatives, milk/alternatives as well as plenty of water). Minimum number of serves from each of these food groups are outlined based on sex (men, women, pregnant women, breastfeeding women) and age (19-50 years, 51-70 years and 70+ years). The dietary prescription will incorporate negotiated food swaps as per the participant’s food preferences to ensure alignment with the Australian Dietary Guidelines as above outlined. The advice will be followed by nutrition counselling and include the provision of staged nutrition education and skill development tailored to the participant based on their compliance with the dietary prescription, lifestyle requirements and any specific MS related symptoms/disability needs. The progression rate and structure will vary between individuals, reflecting their unique capabilities, barriers, and motivation, while remaining grounded in behaviour change strategies. Topics discussed during telehealth consultations may include an introduction to the Australian Dietary Guidelines, education on the importance and benefit of a healthy diet on MS, dietary balance and portion control to support weight management; hydration, food label reading, choosing suitable snacks, avoiding restrictive behaviours, meal preparation and maintenance of new eating patterns. Dietary resources developed by our team, as well as those available on the Eat for Health website [https://www.eatforhealth.gov.au/] may also be provided to participants to support portion control and categorisation of foods according to their food group. The exercise element of the trial will aim to increase participants exercise behaviours. Participants in the intervention arm will follow a progressive 6-month physical activity program of aerobic and resistance exercise a minimum of four times per week. The progression will facilitate the participant in achieving the MS physical activity guidelines for those with mild to moderate disability [Kalb et al, Mult Scler. 2020; 26(12): 1459-1469] within two-months and is designed to be independently sustainable in the long term. For those with minimal current exercise levels (considered general exercisers), these guidelines encourage moderate intensity aerobic exercise at least 2x/week for a minimum of 30 minutes/session and resistance strength training a minimum of 2x/week plus resistance exercises 2x/week. Those with advanced fitness levels are encouraged to engage in moderate to vigorous intensity aerobic exercise 5x/week for 40 minutes/session and resistance strength training 2x/week plus resistance exercises 2x/week. Participants will be allocated to either the general exercise or advanced exercise group based on their initial self-report of their exercise behaviour and via confirmation to the research team via telephone discussion. Once allocated, all general exercise intervention participants will follow the same first two weeks of 10 minutes of walking a minimum of 2x/week and one set of five resistance exercises 2x/week. Similarly, once allocated, all advanced exercise intervention participants will follow the same first two weeks of 10 minutes or walking a minimum of 4x/week and one set of five resistance exercises 2x/week. Topics discussed during telehealth consultations may include introduction to the MS physical activity guidelines, education on the importance and benefit of regular exercise on MS, demonstrations of resistance training exercises, review of exercises by participants to ensure correct execution and maintenance of new exercise patterns. Within the general and advanced groups, the progression rate will vary from one of three options (discussed between the participants and healthcare professional in week two), gradual (General exercise group: ten weeks to achieve the moderate exercise guidelines, Advanced exercise group: 14 weeks to achieve the advanced exercise guidelines ), medium (General exercise group: eight weeks to achieve the moderate exercise guidelines, Advanced exercise group: twelve weeks to achieve the advanced exercise guidelines) and paced (General exercise group: six weeks to achieve the moderate exercise guidelines, Advanced exercise group: ten weeks to achieve the advanced exercise guidelines)) [Learmonth, et al. 2021. Contemp Clin Trials. 2021 Mar;102:106281]. The progression rate will initially be set as a goal in the discussion between participant and healthcare professional in the second week of the program. The aerobic exercise will be based on a brisk-walking intervention using a mobile application to monitor step count. Level of intensity will be measured via the rate of perceived effort scale with a general target of 11-13 for general aerobic exercisers and 13-15 for advanced aerobic exercisers. The resistance exercises will be delivered via one-on-one, coached demonstrations during the follow up telehealth appointments and participants will be provided a resistance tube via post. Participants will be supported to reach a target of up to 3x sets of 8-15 reps for each resistance exercise, a minimum of 2x/week. Resistance exercises that may include, but are not limited to squats, chest press, lunges, tube rows, hip thrusts, shoulder press and calf raises. Balance and flexibility exercises will also be incorporated to suit participants needs and abilities. The psychological element of the trial will focus on tested approaches to behaviour change with people living with MS to facilitate improved maintenance of weight loss. The psychological components underpinning the intervention will similarly follow a staged approach that introduces the behaviour change approach to weight management. This may include an introduction to the behaviour change, setting realistic outcome expectations, defining and explaining the benefits of self-monitoring including examples of behaviours which can be self-monitored; SMART goal setting, defining and explaining the role that self-efficacy has on long-term diet/exercise participation; managing unhelpful thoughts, overcoming barriers including problem solving and identifying solutions. During the telehealth consultations and in line with diet and exercise goals, the healthcare professional will also encourage the identification of facilitators to maintain progress, based on SMART goal setting of the participant for long-term weight maintenance. By the end of the intervention the participants will have learnt skills related to problem solving, awareness of thoughts and emotions, skilled breathing, pleasant activities and mindfulness. The progression rate of these skills will be tailored to suite the participant goals, needs and abilities as related to diet and exercise. It is important to note that each 1-hour telehealth session will be structured to reflect the participant’s individual needs and preferences for diet and exercise, consistent with a person-centred approach and reflective of real-world clinical practice. As an example, the session may be divided into approximately ~20-25 minutes focusing on dietary advice and ~20-25 minutes on exercise, however, these proportions may vary depending on participant goals and engagement. Psychological behaviour change principles will underpin all conversations on diet and exercise. Participants will be encouraged to drive the conversation, enabling the healthcare professional to tailor advice and support that aligns with their unique context and readiness for change.