Effects of a Weight Loss Program in People With Hip Osteoarthritis

NCT04825483 | Completed DMC

• 1 other identifier: 20516
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Osteoarthritis; Overweight and Obesity

Keywords

Osteoarthritis; Osteoarthritis, hip; Obesity; Overweight; Weight loss; Arthritis; Joint diseases; Musculoskeletal diseases; Telehealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Severity of hip pain

  Change between baseline and 12 months post-randomisation

• Body weight

  Change between baseline and 6 months post-randomisation

• Body weight

  Change between baseline and 12 months post-randomisation

• Body Mass Index (BMI)

  Change between baseline and 6 months post-randomisation

• Body Mass Index (BMI)

  Change between baseline and 12 months post-randomisation

Study Arms (2)

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.

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.

Other: Exercise

Interventions

Weight loss OTHER

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.

Weight loss and exercise

Exercise OTHER

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.

Exercise only; Weight loss and exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

University of Melbourne

Carlton, Victoria, 3010, Australia

Location

Related Publications (2)

• 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.

  PMID: 40759020 DERIVED

• 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.

  PMID: 35248012 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Overweight; Obesity; Osteoarthritis; Weight Loss; Arthritis; Joint Diseases; Musculoskeletal Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Rheumatic Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kim Bennell, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will not be informed about the study hypotheses, until the study is completed, at which time they will be provided a lay summary of study findings. However, the components of each treatment arm will be disclosed during recruitment, allowing us to test the interventions in a way whereby potential participants are fully informed about the nature of the components before deciding whether to participate. As the primary and some of the secondary outcomes are participant-reported, participants are also the outcome assessors and are unblinded. Physiotherapists and dietitians will not be blinded to group allocation or study hypothesis. Staff collecting the secondary outcome body composition data will be blinded to group allocation. Research staff administering and entering the participant-reported data will be blinded. Statistical analyses will be performed blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A superiority, 2-group, parallel randomised controlled trial

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: June 16, 2021
• Primary Completion: July 24, 2023
• Study Completion: January 27, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Available upon publication of results
• Access Criteria: Upon reasonable request

Locations

AU (1)