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临床试验/NCT05993169
NCT05993169终止不适用

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

Jacob M. Elkins1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
Height (in cm)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

Primary care provider will be blind to subject arm,

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Control

No Intervention

Normal Care

Nutritional consultation

Experimental

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.

干预措施: Body Composition optimization visits (Other)

结局指标

主要结局

Height (in cm)

时间窗: 1 year

Patient height will be recorded at each visit

Body mass index

时间窗: 1 year

Patient BMI will be calculated by (weight in kg/height in meters squared)

Body fat mass

时间窗: 1 year

Body fat mass will be obtained by an InBody machine at each visit

Weight (in kg)

时间窗: 1 year

Patient weight will be recorded at each visit

Hand grip strength (measured in kg)

时间窗: 1 year

Hand grip strength will be obtained at each visit

Skeletal muscle mass

时间窗: 1 year

Skeletal Muscle mass will be obtained by an InBody machine at each visit

次要结局

未报告次要终点

研究者

发起方
Jacob M. Elkins
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jacob M. Elkins

Assistant Professor

University of Iowa

研究点 (1)

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