Clinical trial NCT04825483: Effects of a Weight Loss Program in People With Hip Osteoarthritis
Official title: Effects of a Weight Loss Program in People With Hip Osteoarthritis: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Overweight and Obesity
Keywords: Osteoarthritis
Osteoarthritis, hip
Obesity
Overweight
Weight loss
Arthritis
Joint diseases
Musculoskeletal diseases
Telehealth
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A superiority, 2-group, parallel randomised controlled trial
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Severity of hip pain
timeFrame: Change between baseline and 6 months post-randomisation
Secondary outcomes:
measure: Severity of hip pain
timeFrame: Change between baseline and 12 months post-randomisation
measure: Body weight
timeFrame: Change between baseline and 6 months post-randomisation
measure: Body weight
timeFrame: Change between baseline and 12 months post-randomisation
measure: Body Mass Index (BMI)
timeFrame: Change between baseline and 6 months post-randomisation
measure: Body Mass Index (BMI)
timeFrame: Change between baseline and 12 months post-randomisation
measure: Total body fat mass
timeFrame: Change between baseline and 6 months post-randomisation
measure: Hip pain
timeFrame: 6 months post-randomisation
measure: Hip pain
timeFrame: 12 months post-randomisation
measure: Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
timeFrame: Change between baseline and 6 months post-randomisation
measure: Hip Osteoarthritis Outcome Scale (HOOS) Pain Subscale
timeFrame: Change between baseline and 12 months post-randomisation
measure: Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
timeFrame: Change between baseline and 6 months post-randomisation
measure: Hip Osteoarthritis Outcome Scale (HOOS) Activities of daily living subscale
timeFrame: Change between baseline and 12 months post-randomisation
measure: Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
timeFrame: Change between baseline and 6 months post-randomisation
measure: Hip Osteoarthritis Outcome Scale (HOOS) Quality of Life Subscale
timeFrame: Change between baseline and 12 months post-randomisation
measure: Quality of life (AQoL-8D)
timeFrame: Change between baseline and 6 months post-randomisation
measure: Quality of life (AQoL-8D)
timeFrame: Change between baseline and 12 months post-randomisation
measure: Global rating of change in physical activity
timeFrame: 6 months post-randomisation
measure: Global rating of change in physical activity
timeFrame: 12 months post-randomisation
measure: Global rating of overall change in hip problem
timeFrame: 6 months post-randomisation
measure: Global rating of overall change in hip problem
timeFrame: 12 months post-randomisation
measure: Visceral fat mass
timeFrame: Change between baseline and 6 months post-randomisation
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Kim Bennell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall 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.