Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000578404
Ethics application status
Approved
Date submitted
23/04/2025
Date registered
4/06/2025
Date last updated
4/06/2025
Date data sharing statement initially provided
4/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle clinical trial for weight loss in adults living with multiple sclerosis (MS).
Scientific title
The effect of an interdisciplinary, lifestyle management, randomised controlled trial of weight as a comorbidity among adults living with relapsing-remitting multiple sclerosis (MS).
Secondary ID [1] 314124 0
None
Universal Trial Number (UTN)
Trial acronym
HALT-MS: [self]-management using a Holistic Approach of Lifestyle-based Telehealth for MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-remitting multiple sclerosis (RRMS) 336929 0
Overweight 336930 0
Condition category
Condition code
Neurological 333396 333396 0 0
Multiple sclerosis
Diet and Nutrition 333397 333397 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330704 0
Lifestyle
Comparator / control treatment
Participants in the control group will receive usual care delivered by a healthcare professional (nurse) who will be trained in MS care based on the "Brain Health in MS: A nursing resource" guide to provide usual care, based on a primary care model. All sessions will be conducted one-on-one via telehealth to mirror the intervention arm's delivery mode and maintain consistency in contact time. Adherence will be monitored via food and exercise diaries.

Usual care delivered to the control group will include standard dietary advice based on the Australian Guide to Healthy Eating, including provision of associated nutrition resources available on the Eat for Health website. Physical activity guidance will be based upon the most recent MS physical activity guidelines [Kalb et al, Mult Scler. 2020; 26(12): 1459-1469] which encourage 2x sessions/week of 30 minutes of moderate intensity aerobic exercise and 2x sessions/week of resistance exercise. Those who are already exercising at that level will be encouraged to safely do more by the healthcare professional. Psychological support will focus on symptom management strategies (eg., sleep and stress management), as would be encouraged by general practitioners, MS nurses and neurologists as part of routine care. Therefore, topics discussed during telehealth consultations may include introduction to the Australian Dietary Guidelines and MS physical activity guidelines, portion size, aerobic exercise, resistance training & demonstration of exercises, strategies to deal with stress and other MS-related symptoms.

Similar to the intervention-arm, it is important to note that each 1-hour telehealth session will be flexibly structured to reflect the participant’s individual needs and preferences for weight management strategies, 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. Therefore, to replicate the intervention arm format, all control participants will attend one-on-one telehealth consultations at the same timepoints as the intervention group: 2, 4, 6, 8, 16, 20 weeks. Each session will last ~1 hour, delivered over a 6-month period.
Control group
Active

Outcomes
Primary outcome [1] 340973 0
Body weight
Timepoint [1] 340973 0
Body weight (kg), measured in duplicate using digital scales, will be self-reported by the participants at baseline, 3 and 6 months of the intervention phase, and 6 months post-intervention.
Secondary outcome [1] 445659 0
Composite outcomes of feasibility of the intervention procedures
Timepoint [1] 445659 0
- Recruitment rate will be calculated at baseline. - Adherence rates will be calculated at baseline and 6 months of the intervention phase. - Retention rate will be calculated at baseline and 6 months of the intervention phase, and 6 months post-intervention.
Secondary outcome [2] 445660 0
Composite outcomes of acceptability of the intervention procedures
Timepoint [2] 445660 0
- Acceptability survey will be completed at 6-months of the intervention phase. - Time burden calculations will be completed at baseline and 6 months of the intervention phase, and 6 months post-intervention.

Eligibility
Key inclusion criteria
- Persons aged greater than or equal to 18 years of age,
- Community dwelling,
- Body mass index (BMI) greater than or equal to 25kg/m2 and less than 40kg/m2
- A self-reported and neurologist confirmed diagnosis of clinically definite relapsing remitting-MS (using McDonald criteria)
- Patient Determined Disease Steps (PDDS) equivalent of an Expanded Disability Status Scale (EDSS) less than 4 [Learmonth YC, et al. BMC Neurol. 2013 Apr 25;13:37].
- Diagnosed more than 12 months prior to enrolment in the study
- On stable (minimum previous six months) disease modifying therapy.
- Access to a telephone and/or a computer with Internet access and be able to provide informed consent to participate in the intervention and assessment procedures.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Persons aged greater than or equal to 65 years (elderly)
- BMI greater than or equal to 40kg/m2 (obese class III),
- Primary-progressive or secondary-progressive MS phenotypes,
- Patient Determined Disease Steps (PDDS) equivalent of an Expanded Disability Status Scale (EDSS) greater than or equal to 4 (early cane) [Learmonth YC, et al. BMC Neurol. 2013 Apr 25;13:37],
- Inability to understand and communicate in the English language,
- MS relapse within the six months prior to enrolment in the study,
- Currently participating in a weight loss intervention, using synchronous weight loss therapies (eg., ozempic [semaglutide], saxenda [liraglutide] or duromine etc) or recent weight loss of greater than or equal to 10% total body weight in previous 12 months to enrolment in the study,
- Pregnant, planning pregnancy or breastfeeding women,
- At the Neurologist’s direction (i.e. concerns about safety).

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)
Allocation will be concealed via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will first complete an initial screening survey online that is shared with study advertisements. If they meet the inclusion criteria, the project manager will then verify their eligibility via a follow up telephone call. Blinded randomisation will then be conducted and performed remotely by a biostatistician independent to the data collection procedures using computer-generated, block randomisation sequences using STATA (STATA V18, StataCorp LP, College Station Tx). Randomisation will be stratified 1:1 to each arm according to sex based on MS prevalence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be analysed using linear mixed or generalised linear mixed models. These models allow for longitudinal analysis of data with missing time points. Data analysis will be performed using STATA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2025
Actual
Date of last participant enrolment
Anticipated
4/12/2025
Actual
Date of last data collection
Anticipated
4/12/2026
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318632 0
Charities/Societies/Foundations
Name [1] 318632 0
MS Australia
Country [1] 318632 0
Australia
Primary sponsor type
Individual
Name
Yasmine Probst, University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 321050 0
Individual
Name [1] 321050 0
Olivia Wills, University of Wollongong
Address [1] 321050 0
Country [1] 321050 0
Australia
Other collaborator category [1] 283457 0
Individual
Name [1] 283457 0
Yvonne Learmonth, Murdoch University
Address [1] 283457 0
Country [1] 283457 0
Australia
Other collaborator category [2] 283458 0
Individual
Name [2] 283458 0
Litza Kiropoulos, University of Melbourne
Address [2] 283458 0
Country [2] 283458 0
Australia
Other collaborator category [3] 283459 0
Individual
Name [3] 283459 0
Anneke Van Der Walt, Monash University
Address [3] 283459 0
Country [3] 283459 0
Australia
Other collaborator category [4] 283460 0
Individual
Name [4] 283460 0
Marijka Batterham, University of Wollongong
Address [4] 283460 0
Country [4] 283460 0
Australia
Other collaborator category [5] 283461 0
Individual
Name [5] 283461 0
Rebekkah Middleton, University of Wollongong
Address [5] 283461 0
Country [5] 283461 0
Australia
Other collaborator category [6] 283462 0
Individual
Name [6] 283462 0
Julie Campbell, University of Tasmania
Address [6] 283462 0
Country [6] 283462 0
Australia
Other collaborator category [7] 283463 0
Individual
Name [7] 283463 0
Nenad Naumovski, University of Canberra
Address [7] 283463 0
Country [7] 283463 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317237 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 317237 0
Ethics committee country [1] 317237 0
Australia
Date submitted for ethics approval [1] 317237 0
21/05/2024
Approval date [1] 317237 0
27/11/2024
Ethics approval number [1] 317237 0
2024/164

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

Contacts
Principal investigator
Name 140434 0
Prof Yasmine Probst
Address 140434 0
University of Wollongong, Building 41 sciences, 41 Northfields Avenue, Keiraville. NSW. 2500
Country 140434 0
Australia
Phone 140434 0
+61 2 4221 5302
Fax 140434 0
Email 140434 0
[email protected]
Contact person for public queries
Name 140435 0
Olivia Wills
Address 140435 0
University of Wollongong, Building 41 sciences, 41 Northfields Avenue, Keiraville. NSW. 2500
Country 140435 0
Australia
Phone 140435 0
+61 2 4239 3738
Fax 140435 0
Email 140435 0
[email protected]
Contact person for scientific queries
Name 140436 0
Yasmine Probst
Address 140436 0
University of Wollongong, Building 41 sciences, 41 Northfields Avenue, Keiraville. NSW. 2500
Country 140436 0
Australia
Phone 140436 0
+61 2 4221 5302
Fax 140436 0
Email 140436 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: We will not share individual participant data beyond this project because participants will consent to its use solely within the project's scope. This decision respects our ethical responsibility to protect participant privacy and complies with institution policy and data protection requirements.



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.