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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05993169
• Other study ID #: 202306474
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 14, 2023

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Jacob M. Elkins

Country where clinical trial is conducted

United States, 

Outcome

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