Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001062617
Ethics application status
Approved
Date submitted
7/09/2023
Date registered
4/10/2023
Date last updated
4/10/2023
Date data sharing statement initially provided
4/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Weight for Life™ + Medical Nutrition Therapy a study for adults completing the Healthy Weight for Life Program™
Scientific title
How does adding tailored medical nutrition therapy telehealth counselling impact diet quality in participants of the Healthy Weight for Life™ program?
Secondary ID [1] 310562 0
Nil
Universal Trial Number (UTN)
Trial acronym
HWFL+MNT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 331401 0
obesity 331402 0
type 2 diabetes mellitus 331403 0
osteoarthritis 331404 0
heart disease 331487 0
Condition category
Condition code
Diet and Nutrition 328145 328145 0 0
Obesity
Public Health 328215 328215 0 0
Health promotion/education
Cardiovascular 328216 328216 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 328217 328217 0 0
Diabetes
Musculoskeletal 328218 328218 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will receive the Healthy Weight for Life program + up to 4x medical nutrition therapy telehealth consults (1.5hours) with an Accredited Practising Dietitian over 18-weeks. Participants will received personalised medical nutrition therapy (MNT) focused on improving diet quality. Personalisation will be based on the patient's medical history, current dietary patterns and goals. MNT will include education, goal setting, personalised strategies, behaviour change counselling and provision of resources. All information and resources will be chosen based on the individual participants goals, barriers and current dietary intake this will include reference to HWFL resources and use of a variety of freely available resources that are deemed reputable and relevant to each participant. The resources are from multiple sources and may include reference to websites, freely available nutrition education and resources. Resource selection will be chosen based on the individual consultation. Consultations will occur over video-conference consultation at Week's 0, 7, 13 and 18 in line with each phase of the HWFL program.

The Healthy Weight For Life (HWFL) suite of programs are remotely delivered 3 x 6-week phases totaling 18-week programs focused on weight related health conditions. The programs include a structured portion planning and lifestyle modification system and phased use of KicStart™ VLCD meal replacements (Phase 1: 2 meal replacements, phase 2: 1 replacement and Phase 3: option of a small number intermittent meal replacements). The programs provide individual participants with virtual clinical support by nurses and allied health professionals, education, tools and HWFL resources to help them achieve their weight loss and lifestyle modification goals. The virtual clinical support and advice is provided via phone, SMS, email, private message board from within a personal digital hub and mail. The personal digital hub is a place for participants to communicate with support staff, track and monitor progress and access HWFL resources. Support for all programs is received at Week 1, Week 4, Week 9, Week 15 and Week 18, with additional support offered throughout as needed. Participants participating in the Essentials Plus, Diabetes, Heart and Osteoarthritis versions of the HWFL program will be invited into this study. These programs are all run using the same phases but tailored to heart health, type 2 diabetes, osteoarthritis, people who have one or more existing conditions that don't meet the criteria for any of the heart, diabetes or osteoarthritis programs complete the essentials program. Additionally, participants in the HWFL+MNT consultation arm adherence will also be monitored at each consultation when discussing progression towards goals.
Intervention code [1] 326960 0
Lifestyle
Comparator / control treatment
The comparator is the usual care group. These participants will receive the Healthy Weight for Life program as usual for 18 weeks. At the end of the study participants will be offered a one off 30min telehealth appointment with the dietitian to receive personalised medical nutrition therapy.

The Healthy Weight For Life (HWFL) suite of programs are remotely delivered 3 phase 18-week programs focused on weight related health conditions. Each phase is 6-weeks in duration. The programs include a structured portion planning and lifestyle modification system and phased use of KicStart™ VLCD meal replacements (Phase 1: 2 meal replacements, phase 2: 1 replacement and Phase 3: option of a small number intermittent meal replacements). The programs provide individual participants with virtual clinical support by nurses and allied health professionals, education, tools and resources to help them achieve their weight loss and lifestyle modification goals. The virtual clinical support and advice is provided via phone, SMS, email, private message board from within a personal digital hub and mail. Participants participating in the Essentials Plus, Diabetes, Heart and Osteoarthritis versions of the HWFL program will be invited into this study.
Control group
Active

Outcomes
Primary outcome [1] 336019 0
Diet quality as assessed using the Australian Eating Survey - Heart version
Timepoint [1] 336019 0
Baseline and Week 18 post commencement of HWFL program
Primary outcome [2] 336020 0
Self-reported weight via the HWFL member hub
Timepoint [2] 336020 0
Baseline and Week 18 post commencement of HWFL program
Secondary outcome [1] 426495 0
Self-reported waist circumference via the HWFL member hub
Timepoint [1] 426495 0
Baseline and Week 18 post commencement of HWFL program
Secondary outcome [2] 426496 0
Patient Activation Measures as per the PAM Questionnaire
Timepoint [2] 426496 0
Baseline and Week 18 post commencement of HWFL program
Secondary outcome [3] 426497 0
Program Satisfaction using a process evaluation survey designed specifically for this study
Timepoint [3] 426497 0
Week 18 post commencement of HWFL program

Eligibility
Key inclusion criteria
Eligibility for the HWFL+MNT research study:
• Participants who are eligible for the Healthy Weight for Life (HWFL) program (including both private health insurance funded and self-funded)
• Adults aged 18 years +

Eligibility for the HWFL programs include:
• BMI >=28 kg/m2
• A relevant hospital policy with participating private health funds that has been held for at least 12 months
• Willingness to provide progress data over the course of the 18-week program
• Having not previously participated in a HWFL program funded by the individual’s private health insurance
• Heart HWFL - Being treated for, or have a history of, at least one of the following: high blood pressure, high cholesterol, angioplasty or stent, heart attack/stroke, coronary bypass surgery, cardiac arrhythmia/angina, obstructive sleep apnoea
• Diabetes HWFL – A diagnosis of type 2 diabetes mellitus
• Osteoarthritis HWFL – A diagnosis of symptomatic knee or hip osteoarthritis
• Essentials HWFL – Have one or more existing chronic health condition that is not eligible for heart, diabetes, and osteoarthritis HWFL
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not eligible for the HWFL program
Nil other

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)
Randomisation code will be held by someone external to the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in blocks of 6.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This study is a feasibility study, therefore a sample size of 40 participants was decided to be feasible to test study aims, of whom 20 will receive the HWFL + MNT dietitian telehealth intervention and the other 20 will receive the standard care HWFL program as usual.
Paired t-tests or the non-parametric equivalents will be used to explore the within and between group differences for key study outcomes including self-reported weight and dietary changes. Chi squared tests will be employed to explore difference in categorical variables. Other statistical methods may be employed as deemed necessary to explore the relationship between study outcomes. Open ended qualitative questions from the process evaluation will be explored thematically.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/10/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314766 0
University
Name [1] 314766 0
The University of Newcastle
Country [1] 314766 0
Australia
Funding source category [2] 314768 0
Commercial sector/Industry
Name [2] 314768 0
Prima Health Solutions Pty Ltd
Country [2] 314768 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 316751 0
Commercial sector/Industry
Name [1] 316751 0
Prima Health Solutions Pty Ltd
Address [1] 316751 0
14/10-18 Orchard Rd, Brookvale NSW 2100
Country [1] 316751 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313776 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 313776 0
The University of Newcastle, University Drive, Callaghan, NSW, 2308
Ethics committee country [1] 313776 0
Australia
Date submitted for ethics approval [1] 313776 0
31/05/2023
Approval date [1] 313776 0
29/08/2023
Ethics approval number [1] 313776 0
H-2023-0206

Summary
Brief summary
To test the addition of personally tailored medical nutrition therapy (MNT) telehealth counselling into Prima Health Solution’s current online Healthy Weight for Life™ (HWFL) program, on diet quality over 18-weeks while optimising weight loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129322 0
Dr Erin Clarke
Address 129322 0
Advanced Technology Building Room 205, The University of Newcastle, University Drive, Callaghan, NSW 2308
Country 129322 0
Australia
Phone 129322 0
+61 249218834
Fax 129322 0
Email 129322 0
erin.clarke@newcastle.edu.au
Contact person for public queries
Name 129323 0
Dr Erin Clarke
Address 129323 0
Advanced Technology Building Room 205, The University of Newcastle, University Drive, Callaghan, NSW 2308
Country 129323 0
Australia
Phone 129323 0
+61 249218834
Fax 129323 0
Email 129323 0
erin.clarke@newcastle.edu.au
Contact person for scientific queries
Name 129324 0
Dr Erin Clarke
Address 129324 0
Advanced Technology Building Room 205, The University of Newcastle, University Drive, Callaghan, NSW 2308
Country 129324 0
Australia
Phone 129324 0
+61 249218834
Fax 129324 0
Email 129324 0
erin.clarke@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.