Effects of a Weight Loss Program in People With Hip Osteoarthritis

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Effects of a Weight Loss Program in People With Hip Osteoarthritis: a Randomised Controlled Trial

Conditions
-----------------
Hip Osteoarthritis, Overweight and Obesity

Intervention / Treatment
-----------------
* Other: Weight loss
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A superiority, 2-group, parallel randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss and exercise<br>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. | Other: Weight loss<br>* 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.<br>Other: Exercise<br>* 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.<br>|
| Active Comparator: Exercise only<br>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: Exercise<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change between baseline and 6 months post-randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 . | 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 . | Change between baseline and 12 months post-randomisation | 
| Body Mass Index (BMI) | Calculated from height and weight, in Kg/m2 | Change between baseline and 6 months post-randomisation | 
| Body Mass Index (BMI) | Calculated from height and weight, in Kg/m2 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months post-randomisation | 
| Visceral fat mass | Measured using dual energy x-ray absorptiometry and reported in grams and % of total body mass | Change between baseline and 6 months post-randomisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Osteoarthritis, hip, Obesity, Overweight, Weight loss, Arthritis, Joint diseases, Musculoskeletal diseases, Telehealth