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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04825483




Registration number
NCT04825483
Ethics application status
Date submitted
28/03/2021
Date registered
1/04/2021

Titles & IDs
Public title
Effects of a Weight Loss Program in People With Hip Osteoarthritis
Scientific title
Effects of a Weight Loss Program in People With Hip Osteoarthritis: a Randomised Controlled Trial
Secondary ID [1] 0 0
20516
Universal Trial Number (UTN)
Trial acronym
ECHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 0 0
Overweight and Obesity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Weight loss
Other interventions - Exercise

Experimental: Weight loss and exercise - In addition to the physiotherapist-prescribed exercise program, participants in the weight loss and exercise group will also undergo six consultations with a dietitian. They will undergo a ketogenic very low-calorie diet (VLCD) including meal replacements, with an intensive weight loss phase and weight maintenance phase. The exercise component will be the same as that provided for the exercise only comparator. All dietitian and physiotherapy consultations will be delivered online by video-conference platform.

Active comparator: Exercise only - Participants will undergo five consultations (30-45 minutes) with a physiotherapist over 6 months for prescription of a home-based strengthening exercise program and physical activity plan (to be conducted independently at home), as well as OA education. All consultations will be conducted remotely via video-conference.


Other interventions: Weight loss
Participants will receive resources to support the weight loss program including a recipe book, activities book and "how-to guide". The diet program comprises two phases: 1) intensive weight loss through a ketogenic Very Low Calorie Diet (VLCD), including meal replacements for two meals/day, and 2) transition from ketogenic VLCD onto a longer-term eating plan for weight maintenance. Meal replacements will be provided free of charge for up to 6 months. Participants will be encouraged to lose at least 10% body weight.

Other interventions: Exercise
Participants will receive resources to facilitate the physiotherapy management plan, including information about the video-conference platform, osteoarthritis information, an exercise plan/log book and a booklet of possible exercises. The physiotherapist consultations include a structured, progressive exercise and physical activity plan. Participants will be given exercise resistance bands and a ankle weight for home exercises.

Physiotherapists will choose from a list of exercises, aiming to prescribe 5-6 at once. 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 are encouraged to complete exercises three times per week. Physiotherapists encourage the participant to increase their general and incidental levels of physical/aerobic activity based on their individual needs and goals, as well as their current level of activity.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Severity of hip pain
Timepoint [1] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [1] 0 0
Severity of hip pain
Timepoint [1] 0 0
Change between baseline and 12 months post-randomisation
Secondary outcome [2] 0 0
Body weight
Timepoint [2] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [3] 0 0
Body weight
Timepoint [3] 0 0
Change between baseline and 12 months post-randomisation
Secondary outcome [4] 0 0
Body Mass Index (BMI)
Timepoint [4] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [5] 0 0
Body Mass Index (BMI)
Timepoint [5] 0 0
Change between baseline and 12 months post-randomisation
Secondary outcome [6] 0 0
Total body fat mass
Timepoint [6] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [7] 0 0
Hip pain
Timepoint [7] 0 0
6 months post-randomisation
Secondary outcome [8] 0 0
Hip pain
Timepoint [8] 0 0
12 months post-randomisation
Secondary outcome [9] 0 0
Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
Timepoint [9] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [10] 0 0
Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
Timepoint [10] 0 0
Change between baseline and 12 months post-randomisation
Secondary outcome [11] 0 0
Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
Timepoint [11] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [12] 0 0
Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
Timepoint [12] 0 0
Change between baseline and 12 months post-randomisation
Secondary outcome [13] 0 0
Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
Timepoint [13] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [14] 0 0
Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
Timepoint [14] 0 0
Change between baseline and 12 months post-randomisation
Secondary outcome [15] 0 0
Quality of life (AQoL-8D)
Timepoint [15] 0 0
Change between baseline and 6 months post-randomisation
Secondary outcome [16] 0 0
Quality of life (AQoL-8D)
Timepoint [16] 0 0
Change between baseline and 12 months post-randomisation
Secondary outcome [17] 0 0
Global rating of change in physical activity
Timepoint [17] 0 0
6 months post-randomisation
Secondary outcome [18] 0 0
Global rating of change in physical activity
Timepoint [18] 0 0
12 months post-randomisation
Secondary outcome [19] 0 0
Global rating of overall change in hip problem
Timepoint [19] 0 0
6 months post-randomisation
Secondary outcome [20] 0 0
Global rating of overall change in hip problem
Timepoint [20] 0 0
12 months post-randomisation
Secondary outcome [21] 0 0
Visceral fat mass
Timepoint [21] 0 0
Change between baseline and 6 months post-randomisation

Eligibility
Key inclusion criteria
* American College of Rheumatology classification criteria with pain in the groin or hip region on most days of the past month and femoral or acetabular osteophytes and joint space narrowing (superior, axial and/ or medial) on x-ray;
* aged 50 years or older;
* report history of hip pain = 3months;
* report an average pain score of at least 4 on an 11-point numeric rating scale (anchored at 0=no pain, 10=worst pain imaginable) over the previous week;
* access to a device with internet connection;
* have a BMI >27 kg/m2;
* willing and able give informed consent and participate fully in the interventions and assessment procedures;
* have ability to weigh themselves (e.g. access to scales);
* pass the Exercise and Sports Science Australia stage 1 adult pre-exercise screening system or obtain general practitioner clearance for participation in the study.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* weight >150 kgs (due to the added complexities of additional nutritional requirements for individuals above this weight);
* inability to speak and read English;
* on waiting list for/planning back/lower limb surgery or bariatric surgery in next 12 months;
* previous arthroplasty on affected hip;
* recent hip surgery on affected hip (past 6 months);
* self-reported inflammatory arthritis (e.g. rheumatoid arthritis);
* weight loss of > 2 kg over the previous 3 months;
* already actively trying to lose weight by any of the following mechanisms:

1. using meal replacements for weight loss
2. being a member of a commercial weight loss program (e.g. weight watchers)
3. receiving support from another health care professional for weight loss
4. using any drugs prescribed to aid in weight loss
5. using structured meal programs for weight loss such as 'Lite n' Easy'
* unable to undertake ketogenic VLCD without closer medical supervision including self-reported:

1. diagnosis of Type 1 diabetes
2. Type 2 diabetes requiring insulin or other medication apart from metformin
3. warfarin use
4. stroke or cardiac event in previous 6 months
5. unstable cardiovascular condition
6. fluid intake restriction
7. renal (kidney) problems (unless clearance is obtained from GP, including GP confirmation that estimated glomerular filtration rate >30 mL/min/1.73m2)
* any neurological condition affecting lower limbs;
* pregnancy or planned pregnancy
* vegan dietary requirements due to complexity of delivering a nutritionally complete diet within the ketogenic diet regime.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2024
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Carlton
Recruitment postcode(s) [1] 0 0
3010 - Carlton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kim Bennell, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
PD can be shared

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
Available upon publication of results
Available to whom?
Upon reasonable request
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04825483