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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

Study Summary

This trial will look at whether weight loss prior to TKA can help improve outcomes such as pain, infection, joint function, and hospital readmissions.

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.Check my eligibility
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.See study design
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 below
Select...
I am between 50 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant Attendance Feasibility
Participant Retention Feasibility
Secondary outcome measures
Body Weight (kg)
Fat Free Mass (kg)
Fat Mass (kg)
+2 more

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

Find a Location

Who is running the clinical trial?

South Dakota State UniversityOTHER
19 Previous Clinical Trials
10,016 Total Patients Enrolled
5 Trials studying Obesity
6,142 Patients Enrolled for Obesity
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,240 Total Patients Enrolled
19 Trials studying Obesity
103,582 Patients Enrolled for Obesity
Steve Herrmann, PhDPrincipal InvestigatorUniversity of Kansas Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for this experiment?

"Affirmative. Records hosted on clinicaltrials.gov verify that this medical trial, which was first posted May 1st 2023, is presently enrolling participants. Approximately 30 volunteers must be recruited from a single site."

Answered by AI

What is the goal of this experiment?

"This clinical trial will span a period of 6 months and its primary outcome is to assess the feasibility of participant attendance. Additionally, changes in fat mass, fat free mass, and body weight between study arms are being evaluated using DEXA scans and calibrated scales respectively."

Answered by AI

Am I eligible to partake in this experiment?

"This trial is accepting 30 patients, aged 50 to 75, with a BMI between 35 and 40 kg/m2. All candidates must be registered at KU Health System Department of Orthopedics & Sports Medicine (KUOrtho), have their TKA surgery scheduled 3 months or more from consenting, own an appropriate device for remote telehealth sessions and synchronizing study-related devices."

Answered by AI

Is the enrollment window of this clinical experiment open to individuals aged 55 or older?

"The age range necessary for participation in this research is between 50 and 75 years old."

Answered by AI

What is the current total of participants in this clinical experiment?

"Affirmative, clinicaltrials.gov reports that the trial is actively recruiting participants after being published on May 1st 2023 and updated on November 28th 2023. 30 patients are needed from a single research centre."

Answered by AI
~13 spots leftby Dec 2024