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Trial registered on ANZCTR


Registration number
ACTRN12619001045101
Ethics application status
Approved
Date submitted
9/07/2019
Date registered
24/07/2019
Date last updated
4/08/2020
Date data sharing statement initially provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and diet for people with hip osteoarthritis: the ECHO feasibility study
Scientific title
Exercise and diet for people with hip osteoarthritis who are overweight or obese: the ECHO feasibility study
Secondary ID [1] 298484 0
Nil known
Universal Trial Number (UTN)
U1111-1235-2382
Trial acronym
ECHO: ExerCise and diet for people with Hip Osteoarthritis: a feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 313263 0
Obesity 313264 0
Condition category
Condition code
Musculoskeletal 311707 311707 0 0
Osteoarthritis
Diet and Nutrition 311708 311708 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a diet and exercise program.

Exercise:
Participants will receive six individual consultations with a physiotherapist over 6-months, in addition to educational material (booklets about osteoarthritis and non-surgical management). The physiotherapist consultations will include a structured exercise program. Participants will be given three exercise resistance bands and ankle-cuff weights for home strengthening exercises. The initial physiotherapy consultation will be approximately 45 minutes long, with follow-up consultations being approximately 30 minutes. Consultations are recommended to occur in weeks 1, 3, 7, 11, 16 and 21, but timing can be negotiated between each participant and their physiotherapist. Physiotherapists will choose from a list of exercises and aim to prescribe 5-6 exercises. This will include strengthening exercises (hip abductors/extensors/adductors/flexors) and some functional exercises. The exact number of exercises, as well as sets/repetitions, will be determined in consultation between the physiotherapist and participant. Intensity is determined using a modified Rating of Perceived Exertion (RPE) scale, where it should feel “hard” to “very hard” to perform a full set of each exercises. Participants will be encouraged to complete exercises three times per week. Physiotherapists will encourage the participant to increase their general and incidental levels of physical/aerobic activity. Prescription of exercises/physical activity plans is based on the clinical history and functional ability of the participant. Physiotherapists will encourage the use of a provided logbook to improve adherence and motivation but the logbook will not be collected.

Diet:
Participants will also receive six individual consultations with a dietitian over 6 months to help the participant undertake a weight management program. Participants’ first consultation with the dietitian will be approximately 45 minutes in duration, with follow-up consultations of approximately 30 minutes. Consultations are recommended to occur in weeks 1, 3, 6, 10, 14-17, and 19-23 but timing will be individualised as required. During the initial consultation, appropriate weight loss goals and a management plan are developed. During subsequent consultations, dietitians monitor progress and use motivational interviewing principles and techniques to develop motivation and self-efficacy and provide assistance in overcoming obstacles to completing the agreed self-management plan. Once the participant has reached their target weight, they can choose whether to transition to a weight maintenance phase or continue with the very low calorie (VLE)/ketogenic diet program and aim for further weight loss. Ongoing education, information and advice are key components of the intervention to optimally support weight loss. Resources and strategies will include keeping a food diary and monitoring weight weekly and discussing these with the dietitian.


The VLE/ketogenic diet used will involve replacing two meals, generally breakfast and lunch, with VLE products (Optifast meal replacements, or Optislim). Optifast products provide most of the vitamins, minerals, and metals required for optimal nutrition, and come as bars, shakes, or soups in a variety of flavours. Optifast will be provided to the participants. On the diet, one meal (generally dinner) comprises protein (e.g. white or red meat, fish or seafood, eggs, or tofu) and non-starchy vegetables/salad. In total, the diet contains 800 calories (3280 kilojoules) per day. Participants will be provided with guidelines and recipes for this meal but will have to source ingredients and prepare it themselves.
Participants will be encouraged to aim to lose at least 10% body weight. Once participants reach this target they can choose whether to commence transition to maintenance or continue with the VLE/ketogenic diet program and aim for further weight loss. Transitioning off the VLE/ketogenic diet is done by reintroducing foods containing carbohydrates and moving to only one meal replacement per day. This transition phase usually lasts at least two weeks.

After this, participants commence a healthy eating diet (weight management phase) which is consistent with the principles of the Commonwealth Scientific and Industrial Research Organisation (CSIRO) total wellbeing diet (i.e. high protein, low glycaemic index carbohydrate, low fat). Food choice during this phase is at the discretion of the participant.

Participants are encouraged to weigh themselves regularly thereafter (e.g. once per week). Participants who regain 2 kilograms or more are advised to restart the VLE/ketogenic diet with meal replacements for 1-2 weeks.


Clinicians:
Physiotherapists and dietitians from private practice around metropolitan Melbourne will be recruited to deliver the exercise and diet programs respectively. Physiotherapists who have previously delivered a similar exercise program in people with hip osteoarthritis and who have treated at least 5 individuals with hip osteoarthritis in the last 12 months will be eligible to participate and will attend a face-to-face training session on the protocol and components of this feasibility study, delivered by the research staff.

Dietitians who are delivering the same weight management intervention in the Better Knee, Better Me (BKBM) RCT (ACTRN12618000930280) will deliver the weight loss support for this feasibility study and will already be trained in Motivational Interviewing and relevant OA management. They will be provided with the protocol and appropriate training for this study. As part of the BKBM training, they will have attended a two-day face-to-face Motivational Interviewing course with an external consulting company, a half day workshop in evidence-based management of OA (delivered by members of the BKBM research team) and a 1-hour webinar delivered by the BKBM research team on the specifics of the VLCD.

Delivery of the intervention:
All participants will receive the physiotherapist and dietitian consultations online (i.e. video consultation using a computer and Zoom software).

Videoconferencing software:
Zoom videoconferencing will be used as a platform for video consultations. Zoom provides video, audio and content sharing to enable participant interaction. Participants will be sent instructions on how to set up Zoom and clinicians will be trained in its use. Telephone contact details to access research staff for support will be provided in case participants need additional assistance or encounter technical difficulties.
Intervention code [1] 314732 0
Treatment: Other
Comparator / control treatment
No control group - feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320406 0
This is a composite primary outcome where we aim to determine feasibility of delivering a diet and exercise intervention for people with hip osteoarthritis. Feasibility will be determined in a composite fashion, by looking at participant recruitment rate, participant retention rate and number/nature of adverse events, participant adherence to consultations and qualitative exploration of participant experience of the study methods and intervention. Each of these components and the way they are being measured are described in further detail under separate secondary outcomes.
Timepoint [1] 320406 0
6 months post-baseline
Secondary outcome [1] 372369 0
This is a composite secondary outcome. Qualitative exploration of participant experience of participation in the feasibility study: The overarching goal of the enquiry is to explore the acceptability of the program, which aspects of the program were most successful in enabling participants to adhere to and participate in the program and identify areas for improvement or modification. Semi-structured interviews will be used to allow a rich exploration of participant experiences regarding the following: (1) acceptability of the exercise and diet interventions in principle and practice, (2) barriers and facilitators to participation and adherence to the exercise and diet interventions and (3) experiences and perceived outcomes of participation
Timepoint [1] 372369 0
6 months after baseline
Secondary outcome [2] 372375 0
Self reported body weight in kilograms, as measured on scales at home and reported via online questionnaire
Timepoint [2] 372375 0
baseline, 3 and 6 months
Secondary outcome [3] 372377 0
Videoconferencing software ease of use: Self-reported. Scored on 11-point NRS for “How easy was it to use the videoconferencing software?” from 0 = “Not at all easy” to 10 = “Extremely easy”
Timepoint [3] 372377 0
6 months after baseline
Secondary outcome [4] 372378 0
Global response: overall change in hip pain since starting the study on 7-point scale (“much worse” to “much better”)
Timepoint [4] 372378 0
6 months after baseline
Secondary outcome [5] 372379 0
Global response: overall change in hip physical function since starting the study on 7-point scale (“much worse” to “much better”)
Timepoint [5] 372379 0
6 months after baseline
Secondary outcome [6] 372380 0
Satisfaction with treatment: scored on a 7-point Likert scale (“Extremely unsatisfied” to “Extremely satisfied”) at 6-months.
Timepoint [6] 372380 0
6 months after baseline
Secondary outcome [7] 372381 0
Average overall pain: overall average pain in the past week, measured via an 11-point NRS with terminal descriptors of ‘no pain’ (score 0) and ‘worst pain possible’ (score 10).
Timepoint [7] 372381 0
Baseline, 3 months and 6 months after baseline
Secondary outcome [8] 372383 0
Walking pain: average pain during walking in the past week, measured via an 11-point NRS with terminal descriptors of ‘no pain’ (score 0) and ‘worst pain possible’ (score 10).
Timepoint [8] 372383 0
Baseline, 3 months and 6 months after baseline.
Secondary outcome [9] 372384 0
Physical function: assessed using the physical function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index (Likert version 3.1). This subscale contains 17 questions, each scored from 0-4, giving a range of possible scores from 0 (no dysfunction) to 68 (maximum dysfunction).
Timepoint [9] 372384 0
Baseline, 3 months and 6 months
Secondary outcome [10] 372386 0
Body composition: Total body mass, fat mass and lean mass will be measured using dual-energy x-ray absorptiometry (DEXA). Absolute values will be reported in kg.
Timepoint [10] 372386 0
Baseline and 6 months after baseline
Secondary outcome [11] 372387 0
Adverse events: Any undesirable clinical occurrence in a participant, whether it is considered to be treatment-related or not, that includes a clinical sign, symptom or condition. There are no expected serious adverse events for this study. Possible adverse events include a transient increase in hip pain, and stiffness and swelling due to increased exercise or physical activity and feeling hungry, fatigued, fuzzy-headed or have headaches, and either diarrhoea or constipation during the first week for the VLE/ketogenic diet.

Adverse events will be recorded:
-at the 6-month time point in an open format in the participant questionnaire.
- Participant self-report (participants will also be encouraged in the plain language statement to discuss adverse events with their dietitian and physiotherapist and can report these to the research staff via a study email address or phone provided in the plain language statement.

There are no expected serious adverse events for participants in this study.

There is a small risk of a transient increase in hip pain, stiffness and swelling or discomfort in other parts of the body due to altered/increased exercise or physical activity.

Very Low Energy/ketogenic diet: This can make people feel hungry, fatigued, fuzzy-headed, and have headaches, and either diarrhoea or constipation during the first week. This is to be expected and these symptoms are usually manageable and short-lived.
Timepoint [11] 372387 0
6 months after baseline via questionnaire, and throughout study via contact with study co-ordinator.
Secondary outcome [12] 372622 0
Participant recruitment rate - as measured by the number of eligible participants enrolled per month over the recruitment period
Timepoint [12] 372622 0
6 months after baseline
Secondary outcome [13] 372623 0
Participant retention rate - the percentage of participants completing the 6 month questionnaires and other outcomes
Timepoint [13] 372623 0
6 months after baseline
Secondary outcome [14] 372624 0
Participant adherence as measured by percentage of dietitian consultations attended (recorded in the dietitian treatment notes)
Timepoint [14] 372624 0
6 months after baseline
Secondary outcome [15] 372625 0
Participant adherence as measured by percentage of physiotherapy consultations attended, as noted in the physiotherapist case report form.
Timepoint [15] 372625 0
6 months after baseline
Secondary outcome [16] 372628 0
Self reported adherence to weight loss plan via 11 point numeric rating scale in the participant questionnaire where 0 =“Not at all” to 10=“Completely as instructed” .
Timepoint [16] 372628 0
6 months after baseline
Secondary outcome [17] 372632 0
Self reported adherence to strength exercise plan via 11 point numeric rating scale in the participant questionnaire where 0 =“Not at all” to 10=“Completely as instructed” .
Timepoint [17] 372632 0
6 months after baseline
Secondary outcome [18] 372633 0
Self reported adherence to physical activity plan via 11 point numeric rating scale in the participant questionnaire where 0 =“Not at all” to 10=“Completely as instructed” .
Timepoint [18] 372633 0
6 months after baseline
Secondary outcome [19] 372636 0
Perceived usefulness of Dietitian consultations, measured by 11 point numeric rating scale where 0=not at all useful and 10= extremely useful.
Timepoint [19] 372636 0
6 months after baseline
Secondary outcome [20] 372637 0
Perceived usefulness of Weight management educational resources, measured by 11 point numeric rating scale where 0=not at all useful and 10= extremely useful.
Timepoint [20] 372637 0
6 months after baseline
Secondary outcome [21] 372638 0
Perceived usefulness of the ketogenic diet, measured by 11 point numeric rating scale where 0=not at all useful and 10= extremely useful.
Timepoint [21] 372638 0
6 months after baseline

Eligibility
Key inclusion criteria
i) meet the American College of Rheumatology clinical and radiological criteria for hip osteoarthritis including:
a) aged between 50 and 80 years old
b) pain in the groin or hip region on most days of the past month
c) joint space narrowing and femoral or acetabular osteophytes on x-ray;
ii) report history of hip or groin pain for longer than 3 months;
iii) report a minimum hip/groin pain score of 4 on an 11-point numeric rating scale during walking over the previous week;
iv) have a body mass index (BMI) between 28 kg/m2 and 41 kg/m2;
iii) report a stable weight (less than a 2 kg change over the previous 3 months);
v) able to give informed consent and to participate fully in the intervention and assessment procedures;
vi) willing/able to use the internet for video consultations with the dietitian and physiotherapist; and
vii) have ability to weigh themselves
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
:i) inability to speak English;
ii) on waiting list for or planning spinal/lower limb surgery in next 12 months;
iii) previous arthroplasty on affected hip;
iv) recent hip surgery (past 6 months);
v) self-reported inflammatory arthritis (e.g. rheumatoid arthritis);
vi) any neurological condition affecting lower limbs; viii) inability to safely participate in moderate-intensity exercise as determined by the Exercise and Sports Science Australia pre-exercise screening form.
vii) unable to undertake very low calorie/ketogenic diet for medical reasons including self-reported:
a) diagnosis of Type 1 diabetes;
b) Type 2 diabetes requiring insulin or other medication apart from metformin;
c) warfarin use;
d) stroke or cardiac event in previous 6 months;
e) unstable cardiovascular condition;
f) fluid intake restriction;
g) renal (kidney) problems (an eGFR of <30 mL/min/1.73m2);

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not relevent - non randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2019
Actual
29/08/2019
Date of last participant enrolment
Anticipated
30/09/2019
Actual
9/10/2019
Date of last data collection
Anticipated
30/03/2020
Actual
1/06/2020
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 27146 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 303029 0
Government body
Name [1] 303029 0
National Health and Medical Research Council
Country [1] 303029 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Parkville Victoria 3010
Australia
Country
Australia
Secondary sponsor category [1] 303241 0
None
Name [1] 303241 0
Address [1] 303241 0
Country [1] 303241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303580 0
Human Research Ethics Committee of The University of Melbourne
Ethics committee address [1] 303580 0
Ethics committee country [1] 303580 0
Australia
Date submitted for ethics approval [1] 303580 0
20/05/2019
Approval date [1] 303580 0
05/07/2019
Ethics approval number [1] 303580 0
1954689

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

Contacts
Principal investigator
Name 94150 0
Prof Kim Bennell
Address 94150 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
161 Barry Street
The University of Melbourne
Carlton Victoria 3010
Country 94150 0
Australia
Phone 94150 0
+61383444135
Fax 94150 0
Email 94150 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 94151 0
Michelle Hall
Address 94151 0
ECHO study, CHESM
Department of Physiotherapy
161 Barry Street, Carlton
The University of Melbourne VIC 3010
Country 94151 0
Australia
Phone 94151 0
+61383440556
Fax 94151 0
Email 94151 0
halm@unimelb.edu.au
Contact person for scientific queries
Name 94152 0
Michelle Hall
Address 94152 0
ECHO study, CHESM
Department of Physiotherapy
161 Barry Street, Carlton
The University of Melbourne VIC 3010
Country 94152 0
Australia
Phone 94152 0
+61383440556
Fax 94152 0
Email 94152 0
halm@unimelb.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
No current plan for IPD sharing


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.