RECRUITING

Increasing Physical Activity Through Social Support and Stress Resilience

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 learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience. The primary questions are to determine whether * the tech-enhanced condition lead to greater physical activity over time? * the tech-enhanced condition lead to social support and stress resilience over time? * social support and stress resilience mediate the relationship between the study condition and physical activity? All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience. Participants will: * Use a Garmin wearable device to monitor their physical activity * Be randomly assigned to a basic education condition or tech-enhanced condition * Set achievable goals for weekly physical activity, with incremental increases to achieve 150 minutes per week by the end of the study * Respond to surveys to monitor their social support, stress resilience, quality of life, and depression. The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.

Official Title

Increasing Physical Activity Through Social Support and Stress Resilience (I-PASS) Among Older Adults Living Alone With SCD to Lower ADRD Risk

Quick Facts

Study Start:2025-06-23
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06896825

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:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 60 years or older
  2. * Living alone and community dwelling
  3. * Engaging in 60 minutes or less per week of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
  4. * Self-reported decline in cognitive functioning
  5. * Self-reported ownership of/willingness to use a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a wearable activity monitor).
  6. * Able to read and speak in English. We hope to offer the intervention in Spanish in the future; however, currently, the study materials are only available in English, and participation will require ability to read and respond to study materials.
  1. * Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
  2. * Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
  3. * Plans to relocate out of metropolitan Phoenix, Arizona area in the next 6 months
  4. * Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
  5. * Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Telephone-Montreal Cognitive Assessment (T-MoCA) at the Baseline Session. A score \< 19 is an exclusion criterion.
  6. * Individuals with neurodegenerative (e.g., dementia), developmental (e.g., autism), neurologic (e.g., Parkinson's, epilepsy), or major psychiatric (e.g., bipolar, schizophrenia) diagnoses
  7. * Being previously prescribed one of the 5 approved Alzheimer's medications, including: Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine (Namenda), Memantine + Donepezil (Namzaric)
  8. * Score of 9 or higher on the 15-item Geriatric Depression Scale (GDS) at the Baseline Session \[scores of 9 and higher are indicative of moderate to severe depression\]
  9. * Currently taking 2 or more anti-depression medications
  10. * History of stroke
  11. * Incarcerated individuals (i.e., Prisoners)

Contacts and Locations

Study Contact

Molly Maxfield, PhD
CONTACT
602-496-2311
Molly.Maxfield@asu.edu
Rodney Joseph, PhD
CONTACT
602-496-0772
Rodney.Joseph@asu.edu

Principal Investigator

Molly Maxfield
PRINCIPAL_INVESTIGATOR
Arizona State University

Study Locations (Sites)

Arizona State University
Phoenix, Arizona, 85004
United States

Collaborators and Investigators

Sponsor: Arizona State University

  • Molly Maxfield, PRINCIPAL_INVESTIGATOR, Arizona 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 Date2025-06-23
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy
  • Subjective Cognitive Decline (SCD)
  • Sedentary Behavior
  • Social Isolation in Older Adults