RECRUITING

Testing Responses of Young Adults to Intervention Messages for Promoting Physical Activity Trial

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 goal of this clinical trial is to test a precision (person-specific and context-sensitive) messaging algorithm for increasing physical activity and slowing weight gain in insufficiently-active young adults. The main questions it aims to answer are: * Does physical activity increase more when text messages are sent based on a precision rule for selecting and timing messages compared to when the same message content is selected and sent at random or not at all? * Do biological or social characteristics of young adults make them more likely to respond positively to the precision messaging intervention than either of the other two interventions? Participants will be provided with education about health-enhancing physical activity and given an activity tracker to wear for 12 months. They will then be randomly assigned to one of three groups. Participants in one group (Precision AIM) will receive up to 4 messages/day selected and timed based on a person-specific algorithm that forecasts possible message effects periodically throughout the day. Messages will be drawn from one of three content libraries: move more, sit less, or inspirational quotes. Participants in a second group (Random AIM) will receive 4 messages/day selected at random from the same three content libraries and delivered at random times within their availability window. Participants in the third group (No AIM) will receive not motivational messages but will randomly assigned to the Random AIM group will receive up to 4 messages/day drawn at random from three content libraries at randomly-selected times. Step counts and weight will be assessed at baseline, and at 3 months, 6 months, 12 months, and 18 months. Researchers will compare Precision AIM, Random AIM and No AIM groups to see if physical activity increased more and weight gain was slower in Precision AIM than Random AIM or No AIM after 3, 6, and 12 months of intervention, and 6 months after the intervention is complete (18 months).

Official Title

Testing Responses of Young Adults to Intervention Messages (TRY AIM) for Promoting Physical Activity Trial

Quick Facts

Study Start:2023-03-31
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05794178

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 29 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * own an iPhone or Android smartphone that they would be willing to download the Fitbit app onto and sync with a Fitbit tracker and a custom, AIM app
  2. * willing to wear a Fitbit tracker almost continually (23.5 hours/day) for a 12- month period of time
  3. * free of visual impairment that would interfere with the receipt of text messages on their phone
  4. * capable of reading, speaking and understanding English and of giving informed consent
  5. * willing to complete a full 18-month study protocol
  1. * self-report sufficient aerobic activity to meet 2018 Physical Activity Guidelines for American adults
  2. * research-grade accelerometer records sufficient aerobic physical activity to meet 2018 Physical Activity Guidelines for American adults
  3. * living outside the continental US
  4. * one or more contraindications to physical activity
  5. * require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity
  6. * pregnant or planning to become pregnant within the next 12 months
  7. * prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome
  8. * concurrent participation in another research study involving physical activity or weight loss
  9. * planning to have surgery or relocate outside the continental US within the next year.

Contacts and Locations

Study Contact

Gabby Ryan, MA
CONTACT
814-865-7935
gabby.ryan@psu.edu

Principal Investigator

David E Conroy, PhD
PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Constantino M Lagoa, PhD
PRINCIPAL_INVESTIGATOR
The Pennsylvania State University

Study Locations (Sites)

The Pennsylvania State University
University Park, Pennsylvania, 16802
United States

Collaborators and Investigators

Sponsor: Penn State University

  • David E Conroy, PhD, PRINCIPAL_INVESTIGATOR, The Pennsylvania State University
  • Constantino M Lagoa, PhD, PRINCIPAL_INVESTIGATOR, The Pennsylvania State 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 Date2023-03-31
Study Completion Date2026-11

Study Record Updates

Study Start Date2023-03-31
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Physical Inactivity
  • Weight Gain