What side effects are associated with this type of intervention?

Common treatments for obesity, such as caloric restriction, increased physical activity, and behavioral counseling, can have several side effects. Caloric restriction may lead to nutritional deficiencies, fatigue, dizziness, and gallstones. Increased physical activity can result in musculoskeletal injuries, particularly in those with pre-existing conditions. Behavioral counseling is generally safe but may cause emotional distress as individuals work to change their eating behaviors. These interventions are designed to minimize severe side effects while promoting sustainable weight loss.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that can complement lifestyle interventions such as caloric restriction, increased physical activity, and behavioral counseling. Notable examples include orlistat, which reduces fat absorption; liraglutide, a GLP-1 receptor agonist that helps with appetite control; and semaglutide, another GLP-1 receptor agonist shown to be effective in weight loss. These medications are often used in conjunction with lifestyle changes to enhance weight loss and maintenance outcomes.

What other types of research exist?

Promising novel alternatives for obesity treatment in 2024 include: 1) Bariatric surgery options like laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass, which have shown long-term efficacy in weight loss and comorbidity resolution. 2) Pharmacotherapy with medications such as GLP-1 receptor agonists (e.g., semaglutide) that have demonstrated significant weight loss and improved metabolic outcomes. 3) Endoscopic procedures like intragastric balloons and endoscopic sleeve gastroplasty, which are less invasive than traditional surgery. 4) Emerging technologies such as vagal nerve blockade and gastric electrical stimulation, which offer novel mechanisms for weight management.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

0 / 1Eligibility criteria met

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.

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

470 Previous Clinical Trials

171,392 Total Patients Enrolled

19 Trials studying Obesity

103,582 Patients Enrolled for Obesity

Steve Herrmann, PhDPrincipal InvestigatorUniversity of Kansas Medical Center

~9 spots leftby Dec 2024

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