NCT04825483Completed
Effects of a Weight Loss Program in People With Hip Osteoarthritis
Effects of a Weight Loss Program in People With Hip Osteoarthritis: a Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Apr 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 28 Mar 2021
- Start date
- 16 Jun 2021
- Primary completion date
- 24 Jul 2023
- Lead sponsor
- University of Melbourne
- Diseases
- Obesity
- NCT number
- NCT04825483
What you commit to
- Study type: Interventional
- Participants enrolled: 101
- From 16 Jun 2021 to the primary completion date, 24 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- 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'
Other illness
- any neurological condition affecting lower limbs;
Lab values
- 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)
Other
- weight \>150 kgs (due to the added complexities of additional nutritional requirements for individuals above this weight);
- inability to speak and read English;
- self-reported inflammatory arthritis (e.g. rheumatoid arthritis);
- pregnancy or planned pregnancy
- vegan dietary requirements due to complexity of delivering a nutritionally complete diet within the ketogenic diet regime.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Melbourne Coordinator of this site? Confirm its status | Carlton | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.