An interventional study of Intervention in Osteoarthritis, Knee and Obesity, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
Treatment options for individuals who have advanced knee osteoarthritis (OA) and a body mass index (BMI) ≥35 kg/m2 are limited, and this patient population may be neglected in current clinical care pathways for OA management. These individuals are considered to be at high risk for complications with total knee arthroplasty (TKA), and as a result may not be eligible for this procedure unless they lose significant weight. However, there is limited evidence for endorsing weight loss as beneficial prior to TKA. Further, unsupervised weight loss could put patients at risk for muscle loss and development of sarcopenic obesity, a health condition that negatively impacts mobility and mortality. This suggests that weight loss might not be the primary treatment goal for this patient population. Integrated non-surgical treatment approaches are needed that can target the specific needs of this knee OA patient group. This study will examine the feasibility and acceptability of a personalized, multicomponent intervention, and its effects on body composition and physical function compared to usual care.
The primary objectives of the POMELO study are to determine if a multicomponent behavioural intervention that includes personalized nutrition recommendations, progressive resistance training exercise, and chronic disease self-management support is feasible and acceptable for individuals living with advanced knee OA and a BMI ≥35 kg/m2. The secondary objectives are to assess potential effects of the intervention on muscle mass and physical function compared to usual care. The intervention is delivered over three months, followed by six months of ongoing maintenance support. Assessments are completed at baseline, interim (after the 3 month intervention phase), and at study end (after the 6 month maintenance phase) [for a total study period of 10 months]. This project will inform and influence the future development and implementation of more personalized knee OA treatment approaches for adults with a BMI ≥35 kg/m2 and reduce health disparities in access to effective care. Findings will also contribute to improved health outcomes for this vulnerable patient population, and enhanced delivery of health services by offering an alternative treatment pathway targeted to patient needs.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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Exclusion Criteria:
The intervention group will receive initial nutrition and exercise consultations with a Registered Dietitian (RD) and Clinical Exercise Physiologist (CEP) to personalize the study protocol and recommendations to their needs. The intervention period (3 months) includes: a) whole-body resistance training exercise sessions completed three-times per week (at-home with loaned equipment and/or in-person at the research gym); b) biweekly nutrition education provided through video conferencing; and c) biweekly OA self-management support provided through video conferencing. After the 3 month intervention, participants will receive bimonthly phone calls from a study staff member to encourage continued behavior changes during the 6 month maintenance phase.
Behavioral: Intervention
The control group will follow standard care procedures, which includes their usual activities. The control group will receive bimonthly contact during the study period through phone calls with a study staff member to encourage retention. However no recommendations or advice on nutrition, exercise or self-management will be provided.
Targeted nutrition advice, progressive resistance training exercise, and self-management support
Per-protocol adherence (feasibility)
per-protocol adherence to the intervention \>= 60%
Time frame: at interim (3 months)
Adverse events
rates of adverse events in the intervention and control arms
Time frame: at interim (3 months)
Study completion rates (feasibility)
study completion rates \>= 80%
Time frame: at study completion (10 months)
Acceptability of Intervention Measure (AIM) score
AIM scores compared between the intervention and control groups
Time frame: at interim (3 months) and study completion (10 months)
Qualitative data on participants perceptions of acceptability
qualitative data from open-ended survey and interview questions under each domain of the Theoretical Framework of Acceptability
Time frame: at interim (3 months) and study completion (10 months)
muscle mass
appendicular lean mass assessed by DXA
Time frame: change from baseline to interim (3 months) and study completion (10 months)
physical function (chair stands)
number of chair stands in 30 seconds
Time frame: change from baseline to interim (3 months) and study completion (10 months)
physical function (6MWT distance)
6MWT distance
Time frame: change from baseline to interim (3 months) and study completion (10 months)
muscle quality
change in ultrasound-measured thigh muscle volume and echogenicity
Time frame: change from baseline to interim (3 months) and study completion (10 months)
fat mass
change in fat mass assessed by DXA
Time frame: change from baseline to interim (3 months) and study completion (10 months)
patient-reported health-related quality of life
change in quality of life assessed by EQ-5D
Time frame: change from baseline to interim (3 months) and study completion (10 months)
patient-reported arthritis-related pain and function
change in arthritis-related pain and function assessed by WOMAC
Time frame: change from baseline to interim (3 months) and study completion (10 months)
self-efficacy for managing chronic disease
change in self-efficacy scores assessed by PROMIS
Time frame: change from baseline to interim (3 months) and study completion (10 months)
lipid panel
change in blood assessed lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides)
Time frame: change from baseline to interim (3 months) and study completion (10 months)
c-reactive protein
change in blood assessed c-reactive protein
Time frame: change from baseline to interim (3 months) and study completion (10 months)
insulin
change in blood assessed insulin
Time frame: change from baseline to interim (3 months) and study completion (10 months)
albumin
change in blood assessed albumin
Time frame: change from baseline to interim (3 months) and study completion (10 months)
liver enzymes
change in blood assessed liver enzymes (ALT and GGT)
Time frame: change from baseline to interim (3 months) and study completion (10 months)
glucose
change in blood assessed glucose
Time frame: change from baseline to interim (3 months) and study completion (10 months)
thyroid stimulating hormone
change in blood assessed thyroid stimulating hormone
Time frame: change from baseline to interim (3 months) and study completion (10 months)
resting energy expenditure
change in resting energy expenditure using indirect calorimetry
Time frame: change from baseline to interim (3 months) and study completion (10 months)
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Alberta