Body Composition Optimization Intervention RCT

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity, Morbid
• Intervention / Treatment: Other: Body Composition optimization visits

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Normal Care
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight (in kg)	Patient weight will be recorded at each visit	1 year
Height (in cm)	Patient height will be recorded at each visit	1 year
Body mass index	Patient BMI will be calculated by (weight in kg/height in meters squared)	1 year
Hand grip strength (measured in kg)	Hand grip strength will be obtained at each visit	1 year
Body fat mass	Body fat mass will be obtained by an InBody machine at each visit	1 year
Skeletal muscle mass	Skeletal Muscle mass will be obtained by an InBody machine at each visit	1 year

Collaborators and Investigators

• Sponsor: Jacob M. Elkins

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 202306474

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No