RECRUITING

Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and lung function in patients with cystic fibrosis (CF) who are ages 16-30 years old. 60 adolescents and young adults with CF will be recruited, and 30 volunteers without cystic fibrosis. A total of 40 of these study participants with CF will be asked to return for annual study visits for 2 years after the first visit. The long-term goal of this study is to use the information collected to make decisions about future nutrition monitoring and interventions which help maintain optimal health for individuals with CF.

Official Title

Outcomes Related to Body Composition in Teens and Adults With Cystic Fibrosis (ORBIT-CF)

Quick Facts

Study Start:2019-07-08
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04002882

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.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or cystic fibrosis trans membrane genotyping (CFTR) with two disease causing mutations
  2. 2. pancreatic exocrine insufficiency
  3. 3. ages 16 years and older
  4. 4. clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit
  5. 5. baseline FEV1% predicted ≥40% where baseline is defined as the average of the best FEV1% for each quarter of the calendar year
  6. 6. participation in the Cystic Fibrosis Foundation (CFF) Patient Registry
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Swati Zaveri, PhD
CONTACT
440-778-8373
swati.shital.zaveri@emory.edu
Jessica A Alvarez, PhD, RD
CONTACT
4047271390
jessica.alvarez@emory.edu

Principal Investigator

Jessica A Alvarez, PhD, RD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

University of Alabama at Birmingham (UAB)/Children's of Alabama
Birmingham, Alabama, 35233
United States
Emory University/Children's Hospital of Atlanta (CHOA)
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Jessica A Alvarez, PhD, RD, PRINCIPAL_INVESTIGATOR, Emory University

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 Registration Dates

Study Start Date2019-07-08
Study Completion Date2025-05

Study Record Updates

Study Start Date2019-07-08
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis