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Body Composition Optimization Intervention RCT

Primary Purpose

Obesity, Morbid

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body Composition optimization visits
Sponsored by
Jacob M. Elkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa Hospitals and ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Nutritional consultation

Arm Description

Normal Care

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 2, 2023
Last Updated
September 27, 2023
Sponsor
Jacob M. Elkins
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1. Study Identification

Unique Protocol Identification Number
NCT05993169
Brief Title
Body Composition Optimization Intervention RCT
Official Title
Body Composition Optimization Intervention to Increase Conversion to Surgical Candidacy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
July 18, 2025 (Anticipated)
Study Completion Date
July 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob M. Elkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Primary care provider will be blind to subject arm,
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal Care
Arm Title
Nutritional consultation
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Body Composition optimization visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight (in kg)
Description
Patient weight will be recorded at each visit
Time Frame
1 year
Title
Height (in cm)
Description
Patient height will be recorded at each visit
Time Frame
1 year
Title
Body mass index
Description
Patient BMI will be calculated by (weight in kg/height in meters squared)
Time Frame
1 year
Title
Hand grip strength (measured in kg)
Description
Hand grip strength will be obtained at each visit
Time Frame
1 year
Title
Body fat mass
Description
Body fat mass will be obtained by an InBody machine at each visit
Time Frame
1 year
Title
Skeletal muscle mass
Description
Skeletal Muscle mass will be obtained by an InBody machine at each visit
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Elkins, MD, PHD
Phone
+1 319 335 7529
Email
jacob-elkins@uiowa.edu
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Elkins, MD, PhD
Email
jacob-elkins@uiowa.edu

12. IPD Sharing Statement

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Body Composition Optimization Intervention RCT

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