Hip OsteoarthritisECHONCT04825483
Effects of a Weight Loss Program in People With Hip Osteoarthritis
A study testing Weight loss and Exercise in people with Hip Osteoarthritis and Overweight and Obesity, run by University of Melbourne at 1 site in Australia.
Trial summary
This randomised controlled trial will compare the effects of a weight loss and exercise program to exercise only on clinical outcomes in 100 people with hip osteoarthritis (OA) and overweight or obesity. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Osteoarthritis, Overweight and Obesity
- What is being tested?
- Weight loss and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Jun 2021to 27 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
Show all 24Show fewer
- weight loss of > 2 kg over the previous 3 months;
- already actively trying to lose weight by any of the following mechanisms:
- using meal replacements for weight loss
- being a member of a commercial weight loss program (e.g. weight watchers)
- receiving support from another health care professional for weight loss
- using any drugs prescribed to aid in weight loss
- using structured meal programs for weight loss such as 'Lite n' Easy'
- unable to undertake ketogenic VLCD without closer medical supervision including self-reported:
- diagnosis of Type 1 diabetes
- Type 2 diabetes requiring insulin or other medication apart from metformin
- warfarin use
- stroke or cardiac event in previous 6 months
- unstable cardiovascular condition
- fluid intake restriction
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Weight Loss Program in People With Hip Osteoarthritis: a Randomised Controlled Trial
This randomised controlled trial will compare the effects of a weight loss and exercise program to exercise only on clinical outcomes in 100 people with hip osteoarthritis (OA) and overweight or obesity. The primary aim is to find out whether a weight loss and exercise program will improve hip pain more than an exercise program alone at 6 months follow-up
Read the detailed description
Clinical guidelines recommend exercise as the core treatment for symptoms, but provide conflicting recommendations about weight loss for people with hip OA. Irrefutable health benefits are associated with weight loss for those with overweight or obesity, but it remains uncertain whether weight loss in addition to exercise and regular physical activity is superior to exercise alone for hip OA symptoms.
This study is a randomized controlled trial for which the aim is to determine whether a weight loss and exercise program improves hip pain more than an exercise program alone at 6 months among people with hip OA who have overweight or obesity.
A total of 100 people with hip osteoarthritis and overweight or obesity will be recruited from the community. Participants will be assessed for eligibility, including review of a hip x-ray. They will be enrolled into the study following informed consent and completion of baseline questionnaires and laboratory-based measures. Each participant will be randomly allocated to receive either: a) weight loss plus exercise program or; b) exercise program alone, over 6 months.
The randomisation schedule will be prepared by a biostatistician (permuted block sizes 2 to 6) stratified by site and sex. Participants allocated to the exercise group will be randomly allocated to a physiotherapist. Participants allocated to the exercise plus weight loss group will be randomly allocated to one of the same physiotherapists as the exercise group, and to a dietitian. The schedule will be stored on a password-protected platform at the University of Melbourne and maintained by a researcher not involved in either participant recruitment or administration of outcome measures. Group allocation will be revealed after completion of baseline measures and randomisation.
Dietitians will complete training in best-practice OA management (half day workshop led by investigators), motivational interviewing skills (2-day training course), weight management (the ketogenic very low calorie diet) and trial procedures. Physiotherapists will be trained in trial procedures, best practice OA management, strengthening and physical activity program, behaviour change techniques to promote adherence and resources for use in the program.
Study participants in both groups will attend 5 individual physiotherapy consultations via video-conference over 6 months and will undertake a home-based lower limb muscle strengthening exercise and physical activity program. Those in the weight loss and exercise group will also undertake a ketogenic very low calorie diet (VLCD), which has been demonstrated as a safe and effective means of achieving rapid weight loss in the adult population with overweight/obesity. They will receive meal replacements (maximum 2 per day) for up to 6 months as well as educational resources.
A biostatistician will analyse blinded data. The statistical method will be outlined in a Statistical Analysis Plan.
- Conditions
- Hip Osteoarthritis, Overweight and Obesity
- Being tested
- Weight loss, Exercise
- Keywords
- Osteoarthritis, Osteoarthritis, hip, Obesity, Overweight, Weight loss, Arthritis, Joint diseases, Musculoskeletal diseases, Telehealth
- Medical subject headings
- Osteoarthritis, Hip, Overweight, Obesity, Osteoarthritis, Weight Loss, Arthritis, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossOther
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.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss and exercise | Experimental | 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. Receives: Other: Weight loss; Other: Exercise |
| Exercise only | Active comparator | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of hip pain
Scored on an 11-point Numeric Rating Scale for average hip pain in the last week. Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Measured: Change between baseline and 6 months post-randomisation
Secondary outcomes (21)
Severity of hip pain
Scored on an 11-point Numeric Rating Scale for average hip pain in the last week. Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Measured: Change between baseline and 12 months post-randomisation
Body weight
Measured on home scales and self-reported in kilograms. The percentage of body weight change (baseline-follow up/baseline x100%) will be calculated .
Measured: Change between baseline and 6 months post-randomisation
Body weight
Measured on home scales and self-reported in kilograms. The percentage of body weight change (baseline-follow up/baseline x100%) will be calculated .
Measured: Change between baseline and 12 months post-randomisation
Body Mass Index (BMI)
Calculated from height and weight, in Kg/m2
Measured: Change between baseline and 6 months post-randomisation
Body Mass Index (BMI)
Calculated from height and weight, in Kg/m2
Measured: Change between baseline and 12 months post-randomisation
Total body fat mass
Measured using dual energy x-ray absorptiometry and reported in grams and % of total body mass
Measured: Change between baseline and 6 months post-randomisation
Hip pain
Proportion of participants who meet or exceed the minimal clinical important difference in Numerical Rating Scale for pain (1.8 units). Expressed as percentage relative to number of participants allocated to each group.
Measured: 6 months post-randomisation
Hip pain
Proportion of participants who meet or exceed the minimal clinical important difference in Numerical Rating Scale for pain (1.8 units). Expressed as percentage relative to number of participants allocated to each group.
Measured: 12 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
Scored using 10 questions regarding hip pain in the last week, with Likert response options ranging from no pain to extreme pain. Ranges from 0 to 20 and normalised to 0 - 100 scale. Higher scores indicate less pain.
Measured: Change between baseline and 6 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
Scored using 10 questions regarding hip pain in the last week, with Likert response options ranging from no pain to extreme pain. Ranges from 0 to 20 and normalised to 0 - 100 scale. Higher scores indicate less pain.
Measured: Change between baseline and 12 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
Scored using 17 questions regarding hip function in the last week, with Likert response options ranging from no dysfunction to extreme dysfunction. Ranges from 0 to 68 and normalised to 0 - 100 scale. Higher scores indicate less dysfunction.
Measured: Change between baseline and 6 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
Scored using 17 questions regarding hip function in the last week, with Likert response options ranging from no dysfunction to extreme dysfunction. Ranges from 0 to 68 and normalised to 0 - 100 scale. Higher scores indicate less dysfunction.
Measured: Change between baseline and 12 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
Scored using 4 questions regarding quality of life in the last week, with Likert response options ranging from none to extreme. Ranges from 0 to 16 and normalised to 0 - 100 scale. Higher scores indicate better quality of life.
Measured: Change between baseline and 6 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
Scored using 4 questions regarding quality of life in the last week, with Likert response options ranging from none to extreme. Ranges from 0 to 16 and normalised to 0 - 100 scale. Higher scores indicate better quality of life.
Measured: Change between baseline and 12 months post-randomisation
Quality of life (AQoL-8D)
Scored from 35 questions regarding health-related quality of life in the last week. Ranges from -0.04 to 1.00; higher scores indicate better quality of life.
Measured: Change between baseline and 6 months post-randomisation
Quality of life (AQoL-8D)
Scored from 35 questions regarding health-related quality of life in the last week. Ranges from -0.04 to 1.00; higher scores indicate better quality of life.
Measured: Change between baseline and 12 months post-randomisation
Global rating of change in physical activity
Scored using a 7-point global rating of change Likert scale with response options ranging from "much less" to "much more" when compared to baseline.
Measured: 6 months post-randomisation
Global rating of change in physical activity
Scored using a 7-point global rating of change Likert scale with response options ranging from "much less" to "much more" when compared to baseline.
Measured: 12 months post-randomisation
Global rating of overall change in hip problem
Scored using a 7-point global rating of change Likert scale with response options ranging from "much worse" to "much better" when compared to baseline.
Measured: 6 months post-randomisation
Global rating of overall change in hip problem
Scored using a 7-point global rating of change Likert scale with response options ranging from "much worse" to "much better" when compared to baseline.
Measured: 12 months post-randomisation
Visceral fat mass
Measured using dual energy x-ray absorptiometry and reported in grams and % of total body mass
Measured: Change between baseline and 6 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start16 Jun 2021
- Primary completion24 Jul 2023
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A superiority, 2-group, parallel randomised controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Bennell, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825483
- Sponsor's protocol ID
- 20516
- Acronym
- ECHO
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2021
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PD can be shared
Publications
Hall M, Hinman RS, Knox G, Spiers L, McManus F, De Silva AP, Sumithran P, Harris A, Murphy NJ, Cicuttini F, Hunter DJ, Messier SP, Bennell KL. Efficacy of a Very-Low-Calorie Weight Loss Diet Plus Exercise Compared With Exercise Alone on Hip Osteoarthritis Pain : A Randomized Controlled Trial. Ann Intern Med. 2025 Sep;178(9):1227-1237. doi: 10.7326/ANNALS-25-00045. Epub 2025 Aug 5.
PubMed 40759020Hall M, Hinman RS, Knox G, Spiers L, Sumithran P, Murphy NJ, McManus F, Lamb KE, Cicuittini F, Hunter DJ, Messier SP, Bennell KL. Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial. BMC Musculoskelet Disord. 2022 Mar 5;23(1):215. doi: 10.1186/s12891-022-05128-9.
PubMed 35248012
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Weight Loss Program in People With Hip Osteoarthritis: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04825483
- Acronym / sponsor ID
- ECHO / 20516
- Conditions
- Hip Osteoarthritis, Overweight and Obesity
- Keywords
- Osteoarthritis, Osteoarthritis, hip, Obesity, Overweight, Weight loss, Arthritis, Joint diseases, Musculoskeletal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised controlled trial will compare the effects of a weight loss and exercise program to exercise only on clinical outcomes in 100 people with hip osteoarthritis (OA) and overweight or obesity. The primary aim is to find out whether a weight loss and exercise program will improve hip pain more than an exercise program alone at 6 months follow-up
Detailed description
Clinical guidelines recommend exercise as the core treatment for symptoms, but provide conflicting recommendations about weight loss for people with hip OA. Irrefutable health benefits are associated with weight loss for those with overweight or obesity, but it remains uncertain whether weight loss in addition to exercise and regular physical activity is superior to exercise alone for hip OA symptoms.
This study is a randomized controlled trial for which the aim is to determine whether a weight loss and exercise program improves hip pain more than an exercise program alone at 6 months among people with hip OA who have overweight or obesity.
A total of 100 people with hip osteoarthritis and overweight or obesity will be recruited from the community. Participants will be assessed for eligibility, including review of a hip x-ray. They will be enrolled into the study following informed consent and completion of baseline questionnaires and laboratory-based measures. Each participant will be randomly allocated to receive either: a) weight loss plus exercise program or; b) exercise program alone, over 6 months.
The randomisation schedule will be prepared by a biostatistician (permuted block sizes 2 to 6) stratified by site and sex. Participants allocated to the exercise group will be randomly allocated to a physiotherapist. Participants allocated to the exercise plus weight loss group will be randomly allocated to one of the same physiotherapists as the exercise group, and to a dietitian. The schedule will be stored on a password-protected platform at the University of Melbourne and maintained by a researcher not involved in either participant recruitment or administration of outcome measures. Group allocation will be revealed after completion of baseline measures and randomisation.
Dietitians will complete training in best-practice OA management (half day workshop led by investigators), motivational interviewing skills (2-day training course), weight management (the ketogenic very low calorie diet) and trial procedures. Physiotherapists will be trained in trial procedures, best practice OA management, strengthening and physical activity program, behaviour change techniques to promote adherence and resources for use in the program.
Study participants in both groups will attend 5 individual physiotherapy consultations via video-conference over 6 months and will undertake a home-based lower limb muscle strengthening exercise and physical activity program. Those in the weight loss and exercise group will also undertake a ketogenic very low calorie diet (VLCD), which has been demonstrated as a safe and effective means of achieving rapid weight loss in the adult population with overweight/obesity. They will receive meal replacements (maximum 2 per day) for up to 6 months as well as educational resources.
A biostatistician will analyse blinded data. The statistical method will be outlined in a Statistical Analysis Plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A superiority, 2-group, parallel randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Weight loss and exercise | Experimental | Other: Weight loss, Other: ExerciseIn 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. |
| Exercise only | Active comparator | Other: ExerciseParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (24 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight lossParticipants 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 | Weight loss and exercise |
| ExerciseParticipants 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. | Other | Exercise only, Weight loss and exercise |
Primary outcome
Severity of hip pain
Time frame: Change between baseline and 6 months post-randomisation
Scored on an 11-point Numeric Rating Scale for average hip pain in the last week. Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
21 secondary outcomes
Severity of hip pain
Time frame: Change between baseline and 12 months post-randomisation
Body weight
Time frame: Change between baseline and 6 months post-randomisation
Body weight
Time frame: Change between baseline and 12 months post-randomisation
Body Mass Index (BMI)
Time frame: Change between baseline and 6 months post-randomisation
Body Mass Index (BMI)
Time frame: Change between baseline and 12 months post-randomisation
Total body fat mass
Time frame: Change between baseline and 6 months post-randomisation
Hip pain
Time frame: 6 months post-randomisation
Hip pain
Time frame: 12 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
Time frame: Change between baseline and 6 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
Time frame: Change between baseline and 12 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
Time frame: Change between baseline and 6 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
Time frame: Change between baseline and 12 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
Time frame: Change between baseline and 6 months post-randomisation
Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
Time frame: Change between baseline and 12 months post-randomisation
Quality of life (AQoL-8D)
Time frame: Change between baseline and 6 months post-randomisation
Quality of life (AQoL-8D)
Time frame: Change between baseline and 12 months post-randomisation
Global rating of change in physical activity
Time frame: 6 months post-randomisation
Global rating of change in physical activity
Time frame: 12 months post-randomisation
Global rating of overall change in hip problem
Time frame: 6 months post-randomisation
Global rating of overall change in hip problem
Time frame: 12 months post-randomisation
Visceral fat mass
Time frame: Change between baseline and 6 months post-randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 40759020Hall M, Hinman RS, Knox G, Spiers L, McManus F, De Silva AP, Sumithran P, Harris A, Murphy NJ, Cicuttini F, Hunter DJ, Messier SP, Bennell KL. Efficacy of a Very-Low-Calorie Weight Loss Diet Plus Exercise Compared With Exercise Alone on Hip Osteoarthritis Pain : A Randomized Controlled Trial. Ann Intern Med. 2025 Sep;178(9):1227-1237. doi: 10.7326/ANNALS-25-00045. Epub 2025 Aug 5.
- Derived from this study: PubMed 35248012Hall M, Hinman RS, Knox G, Spiers L, Sumithran P, Murphy NJ, McManus F, Lamb KE, Cicuittini F, Hunter DJ, Messier SP, Bennell KL. Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial. BMC Musculoskelet Disord. 2022 Mar 5;23(1):215. doi: 10.1186/s12891-022-05128-9.
- Individual participant dataSharing planned: Yes. PD can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Bennell, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss and Exercise in people with Hip Osteoarthritis and Overweight and Obesity, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of hip pain (time frame: Change between baseline and 6 months post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825483, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.