Preparing for Kidney Transplant by Attaining a Healthy Weight (FFC)

March 28, 2023 updated by: University of Chicago
The purpose of this study is to determine if an assigned physical fitness program will result in weight loss to prepare patients for kidney transplant.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to prepare subjects for kidney transplant. Patients who are in need of a kidney transplant but are unable to be place on the wait list due to weight will be enrolled in a six month workout program. The workout program will consist of counseling from a registered dietician, personal training from certified trainers and constant health monitoring.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients over 18 years of age and older but less than 65
  • All patients who are currently listed as "inactive" on the University of Chicago kidney transplant wait list
  • Those with a body mass index of 40-44
  • Those with access to the Internet
  • Have transportation to the fitness center (Formula Fitness Center at Union Station location)

Exclusion Criteria:

  • Those patients who are listed "inactive" on the wait-list due to co-morbid conditions other than obesity
  • Those who are unwilling to attend fitness center appointments
  • Those who do not have adequate transportation to the fitness center
  • Those who do not have access to the Internet
  • Those who are not comfortable navigating and using the Internet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Subjects receive a diet plan and exercise regimen.
Other: Exercise
6 months worth of exercise regimen
Dietary supplement: Diet Plan
Each subject will receive a personalized diet plan from nutritionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 6 months
The difference in starting weight and ending weight six months after beginning exercise program will be measured.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB15-1593

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplant

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe