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Weight Loss Intervention for Obesity Before Knee Surgery
N/A
Recruiting
Led By Steve Herrmann, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 50-75 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if losing weight before knee surgery and maintaining it afterward can improve recovery for patients with high BMI. The program includes a strict diet before surgery and a regular diet after, along with exercise and counseling. The goal is to see if this approach reduces complications and improves outcomes.
Who is the study for?
This trial is for individuals aged 50-75 with a BMI of 35 to ≤40 kg/m2, scheduled for total knee replacement surgery at KUOrtho and able to participate in remote sessions via Bluetooth-enabled devices. It's not suitable for those outside this age and BMI range or without the required technology.
What is being tested?
The study tests a weight loss program before knee surgery, including a very low-calorie diet and behavior counseling, followed by a maintenance diet after surgery. Participants are randomly assigned to either this intervention or standard care without dietary advice.
What are the potential side effects?
Potential side effects from the weight loss intervention may include fatigue, nutritional deficiencies, mood changes, or muscle loss due to calorie restriction. Increased physical activity could also lead to joint pain or injury if not properly monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participant Attendance Feasibility
Participant Retention Feasibility
Secondary study objectives
Body Weight (kg)
Fat Free Mass (kg)
Fat Mass (kg)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Multi-component weight loss intervention
Group II: Standard Care ControlActive Control1 Intervention
Standard care
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity, such as caloric restriction, increased physical activity, and behavioral counseling, work through distinct but complementary mechanisms. Caloric restriction reduces energy intake, leading to a negative energy balance and weight loss.
Increased physical activity boosts energy expenditure, aiding in weight loss and helping to maintain muscle mass. Behavioral counseling addresses the psychological and behavioral factors influencing eating and activity habits, supporting the adoption and maintenance of healthier lifestyle changes.
These treatments are vital for obesity patients as they not only facilitate weight loss but also improve overall health, reduce the risk of comorbidities, and enhance the outcomes of surgical interventions like Total Knee Arthroplasty.
Post-operative behavioural management in bariatric surgery: a systematic review and meta-analysis of randomized controlled trials.
Post-operative behavioural management in bariatric surgery: a systematic review and meta-analysis of randomized controlled trials.
Find a Location
Who is running the clinical trial?
South Dakota State UniversityOTHER
20 Previous Clinical Trials
10,076 Total Patients Enrolled
5 Trials studying Obesity
6,142 Patients Enrolled for Obesity
University of Kansas Medical CenterLead Sponsor
517 Previous Clinical Trials
177,411 Total Patients Enrolled
25 Trials studying Obesity
104,130 Patients Enrolled for Obesity
Steve Herrmann, PhDPrincipal InvestigatorUniversity of Kansas Medical Center