Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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™
Query!
Scientific title
How does adding tailored medical nutrition therapy telehealth counselling impact diet quality in participants of the Healthy Weight for Life™ program?
Query!
Secondary ID [1]
310562
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
HWFL+MNT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
overweight
331401
0
Query!
obesity
331402
0
Query!
type 2 diabetes mellitus
331403
0
Query!
osteoarthritis
331404
0
Query!
heart disease
331487
0
Query!
Condition category
Condition code
Diet and Nutrition
328145
328145
0
0
Query!
Obesity
Query!
Public Health
328215
328215
0
0
Query!
Health promotion/education
Query!
Cardiovascular
328216
328216
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Metabolic and Endocrine
328217
328217
0
0
Query!
Diabetes
Query!
Musculoskeletal
328218
328218
0
0
Query!
Osteoarthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
326960
0
Lifestyle
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
336019
0
Diet quality as assessed using the Australian Eating Survey - Heart version
Query!
Assessment method [1]
336019
0
Query!
Timepoint [1]
336019
0
Baseline and Week 18 post commencement of HWFL program
Query!
Primary outcome [2]
336020
0
Self-reported weight via the HWFL member hub
Query!
Assessment method [2]
336020
0
Query!
Timepoint [2]
336020
0
Baseline and Week 18 post commencement of HWFL program
Query!
Secondary outcome [1]
426495
0
Self-reported waist circumference via the HWFL member hub
Query!
Assessment method [1]
426495
0
Query!
Timepoint [1]
426495
0
Baseline and Week 18 post commencement of HWFL program
Query!
Secondary outcome [2]
426496
0
Patient Activation Measures as per the PAM Questionnaire
Query!
Assessment method [2]
426496
0
Query!
Timepoint [2]
426496
0
Baseline and Week 18 post commencement of HWFL program
Query!
Secondary outcome [3]
426497
0
Program Satisfaction using a process evaluation survey designed specifically for this study
Query!
Assessment method [3]
426497
0
Query!
Timepoint [3]
426497
0
Week 18 post commencement of HWFL program
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
• Not eligible for the HWFL program
Nil other
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation code will be held by someone external to the project.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in blocks of 6.
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
9/10/2023
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
30/06/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
30/10/2024
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
314766
0
University
Query!
Name [1]
314766
0
The University of Newcastle
Query!
Address [1]
314766
0
University Drive, Callaghan, NSW 2308
Query!
Country [1]
314766
0
Australia
Query!
Funding source category [2]
314768
0
Commercial sector/Industry
Query!
Name [2]
314768
0
Prima Health Solutions Pty Ltd
Query!
Address [2]
314768
0
14/10-18 Orchard Rd, Brookvale NSW 2100
Query!
Country [2]
314768
0
Australia
Query!
Primary sponsor type
University
Query!
Name
The University of Newcastle
Query!
Address
University Drive, Callaghan, NSW 2308
Query!
Country
Australia
Query!
Secondary sponsor category [1]
316751
0
Commercial sector/Industry
Query!
Name [1]
316751
0
Prima Health Solutions Pty Ltd
Query!
Address [1]
316751
0
14/10-18 Orchard Rd, Brookvale NSW 2100
Query!
Country [1]
316751
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
313776
0
The University of Newcastle Human Research Ethics Committee
Query!
Ethics committee address [1]
313776
0
The University of Newcastle, University Drive, Callaghan, NSW, 2308
Query!
Ethics committee country [1]
313776
0
Australia
Query!
Date submitted for ethics approval [1]
313776
0
31/05/2023
Query!
Approval date [1]
313776
0
29/08/2023
Query!
Ethics approval number [1]
313776
0
H-2023-0206
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
129322
0
Dr Erin Clarke
Query!
Address
129322
0
Advanced Technology Building Room 205, The University of Newcastle, University Drive, Callaghan, NSW 2308
Query!
Country
129322
0
Australia
Query!
Phone
129322
0
+61 249218834
Query!
Fax
129322
0
Query!
Email
129322
0
[email protected]
Query!
Contact person for public queries
Name
129323
0
Dr Erin Clarke
Query!
Address
129323
0
Advanced Technology Building Room 205, The University of Newcastle, University Drive, Callaghan, NSW 2308
Query!
Country
129323
0
Australia
Query!
Phone
129323
0
+61 249218834
Query!
Fax
129323
0
Query!
Email
129323
0
[email protected]
Query!
Contact person for scientific queries
Name
129324
0
Dr Erin Clarke
Query!
Address
129324
0
Advanced Technology Building Room 205, The University of Newcastle, University Drive, Callaghan, NSW 2308
Query!
Country
129324
0
Australia
Query!
Phone
129324
0
+61 249218834
Query!
Fax
129324
0
Query!
Email
129324
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF