RECRUITING

The Fit with Us Study

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

The purpose of this 32 week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one on one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre recorded exercise content and articles for another 8 weeks. After final surveys, participants will have open access to the website for another 16 weeks where we will passively observe their fitbit and website data. The study outcomes are: The effectiveness of the adaptive interventions Exploring mediating and moderating variables Sensitivity analysis of the predictive analytics

Official Title

Precision-based Teleexercise Trial to Increase Adherence in People with Disabilities

Quick Facts

Study Start:2024-09-01
Study Completion:2029-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06207084

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:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * age 18 to 64 years have a permanent mobility impairment has internet access can converse in English
  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

Mohanraj Thirumalai, PhD
CONTACT
205-934-7189
mohanraj@uab.edu
Sangeetha Mohanraj, MS
CONTACT
205-975-0550
sangee@uab.edu

Principal Investigator

Mohanraj Thirumalai, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

Wellness, Health and Research Facility
Birmingham, Alabama, 35209
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Mohanraj Thirumalai, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2024-09-01
Study Completion Date2029-02-01

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2029-02-01

Terms related to this study

Keywords Provided by Researchers

  • telehealth
  • health coaching
  • disability

Additional Relevant MeSH Terms

  • Mobility Limitations
  • Disability Physical
  • Telehealth
  • Health Coaching
  • Physical Activity
  • Behavior, Health
  • EHealth
  • Health Literacy
  • Self Efficacy
  • Fatigue
  • Usability
  • Predictive Model