Body Composition Optimization Intervention RCT

NCT ID: NCT05993169

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2023-12-14

Brief 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.

Detailed 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.

Conditions

Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Normal Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nutritional consultation

Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.

Group Type: EXPERIMENTAL

Body Composition optimization visits

Intervention Type: OTHER

Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.

Interventions

Body Composition optimization visits

Patients who are selected into the body composition optimization (BCO) visits group will attend an extra one hour in-person check-up with Olivia Johnson as part of their regular clinic follow-ups. During their initial BCO visit, patients will complete a hard copy intake form. These BCO visits will take place in the same clinic as the regular visits. These visits will focus on individual concerns and goal-setting. These visits may be changed to online/video follow ups if the patients are finding it difficult to return to main campus that often.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults, at or above 18 years of age
• BMI over 40kg/m2
• Presenting to arthroplasty-obesity clinic with desire for a total joint arthroplasty procedure

Exclusion Criteria

• Has a pacemaker or other electronic pacemaker placement
• Inability to stand unsupported for 60-90 seconds

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacob M. Elkins

OTHER

Sponsor Role: lead

Responsible Party

Jacob M. Elkins

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202306474

Identifier Type: -

Identifier Source: org_study_id