Body Composition Optimization Intervention RCT

Obesity, Morbid Clinical Trial

Official title: Body Composition Optimization Intervention to Increase Conversion to Surgical Candidacy: A Randomized Controlled Trial

Status Terminated

Clinical Trial Summary

This study aims to identify if the addition of structured nutrition/weight loss counseling to patients at the bariatric clinic can increase the conversion from bariatric clinic to surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA measurements.

Clinical Trial Description

Obesity, at a BMI exceeding 40kg/m2 (class III) obesity, is a major risk factor for osteoarthritis (OA). In arthroplasty (joint replacement), patients in this population are routinely turned away due to surgeons refusing surgical treatment in patients above arbitrary BMI thresholds (typically 35 or 40 kg/m2). Due to this, patients often turn to simple weight loss to fall below these thresholds. Simple weight loss, which can include loss of muscle mass, has been proven ineffective, counterproductive, and to be an additional risk factor for surgery. To combat this, efforts in our dedicated bariatric clinic have been made to encourage muscle mass gain and body fat loss over simple weight loss methods where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers. Our department is a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA.

This study is a randomized controlled trial which aims to recruit adult patients with class III obesity who present to the bariatric arthroplasty clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass (as standard of care in this clinic), study participants will be randomly assigned to one of two cohorts: the study group who will receive nutritional and exercise consultation/intervention, or the control group who will only receive the individual body composition coaching that is standard practice at the bariatric clinic.

This study aims to identify if the addition of structured nutrition/weight loss counseling to patients at the bariatric clinic can increase the conversion from bariatric clinic to surgical candidacy from (the current) 11% to a goal of 20% by way of tracking their BIA measurements. ;

Related Conditions & MeSH terms

• Obesity, Morbid

• NCT number: NCT05993169
• Study type: Interventional
• Source: University of Iowa
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2023
• Completion date: December 14, 2023