Body Composition Optimization Intervention RCT

NCT05993169 | Terminated DMC

• 1 other identifier: 202306474
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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.

Other: Body Composition optimization visits

Interventions

Body Composition optimization visits 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.

Nutritional consultation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jacob M. Elkins: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Primary care provider will be blind to subject arm,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 15, 2023
• Study Start: September 15, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

US (1)