Increasing Physical Activity Through Social Support and Stress Resilience

NCT06896825 | Recruiting DMC

• 2 other identifiers: STUDY000203261P30AG086561-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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 7000 average daily steps 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in accelerometer-measured moderate to vigorous physical activity

  ActiGraph GT9X Link Activity monitors worn on non-dominant wrist during waking hours 7 consecutive days will provide objective measure of 1) average daily steps and 2) moderate to vigorous activity prior to and after the intervention. GTX9X data (collected in raw format) will be aggregated for analysis to epochs of 60 secs or less for comparability to other studies.

  One week at baseline and one week after intervention concludes

• Change in self-reported physical activity

  Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.

  Reported at baseline and after the 3 month intervention

Secondary Outcomes (13)

• Objective Stress Resilience

  Assessed at baseline and after the 3 month intervention

• Self-reported stress

  Assessed at baseline, end of month 1, end of month 2, and end of month 3

• Brief Resilience Scale

  Assessed at baseline, end of month 1, end of month 2, and end of month 3

• Social Isolation

  Assessed at baseline, end of month 1, end of month 2, and end of month 3

• Self-reported loneliness

  Assessed at baseline, end of month 1, end of month 2, and end of month 3

Other Outcomes (11)

• Cognitive Health

  Assessed during online eligibility screening and after the 3 month intervention

• Functional Activities

  Assessed at baseline and after the 3 month intervention

• Change in Garmin-assessed physical activity

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Tech-enhanced condition

EXPERIMENTAL

Participants in the tech-enhanced condition will receive access to a study specific website (to be developed into an app) and guided use via individual coaching sessions delivered on Zoom. Coaching sessions will align with and reinforce website content, which includes information about the importance of and strategies to increase physical activity, social support, and stress resilience.

Behavioral: Self-monitoring

Control condition

ACTIVE COMPARATOR

Participants in the control condition will receive a study-specific manual containing basic education about the importance of and strategies to increase physical activity, social support, and stress resilience.

Behavioral: Self-monitoring

Interventions

Self-monitoring BEHAVIORAL

All participants will receive a Garmin and use the associated app to monitor their weekly physical activity. Enrolled participants are insufficiently active (engaging in 60 minutes or less of moderate to vigorous physical activity per week) and will receive weekly text messages to incrementally increase physical activity over the course of the study. Goals will be 20% greater than the average daily steps from the previous week, with the ultimate goal of reaching 7000 average daily steps. 7000 average daily steps was selected based on recent findings that it is associated with clinically meaningful health outcomes and being an achievable target for most adults.

Control condition; Tech-enhanced condition

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60 years or older
• Living alone and community dwelling
• Engaging in 60 minutes or less per week of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
• Self-reported decline in cognitive functioning
• 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).
• 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.

You may not qualify if:

• Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
• Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
• Plans to relocate out of metropolitan Phoenix, Arizona area in the next 6 months
• Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
• Individuals with neurodegenerative (e.g., dementia), developmental (e.g., autism), neurologic (e.g., Parkinson's, epilepsy), or major psychiatric (e.g., bipolar, schizophrenia) diagnoses
• Being previously prescribed one of the 5 approved Alzheimer's medications, including: Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine (Namenda), Memantine + Donepezil (Namzaric)
• Score of 9 or higher on the 15-item Geriatric Depression Scale (GDS) at the Baseline Session \[scores of 9 and higher are indicative of moderate to severe depression\]
• History of stroke
• Incarcerated individuals (i.e., Prisoners)

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Molly Maxfield

  Arizona State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Maxfield, PhD

CONTACT

602-496-2311; Molly.Maxfield@asu.edu

Rodney Joseph, PhD

CONTACT

602-496-0772; Rodney.Joseph@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

US (1)