An interventional study of Self-monitoring in Healthy, Subjective Cognitive Decline (SCD) and Sedentary Behavior, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Arizona State University · Not applicable, Interventional, and Treatment
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
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:
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 86 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months
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.
Time frame: Assessed at baseline and 3-months
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.
Time frame: Assessed at baseline and 3-months
Objective Stress Resilience
At baseline and 3 months, participants will have blood drawn to assess glial fibrillary acidic protein, an indicator of stress which has also been associated with neurocognitive disorders.
Time frame: Assessed at baseline and 3-months
Self-reported stress
The 14-item Perceived Stress Scale, with items rated on a 5 point scale (0 to 4). Sum scores are calculated. Possible values range from minimum of 0 to maximum of 56. Higher scores indicate greater perceived stress.
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Brief Resilience Scale
The 6-item Brief Resilience Scale assesses ability to recover from or adjust to challenges. Items are rated on a 5 point scale. Mean scores are calculated. Possible scores range from a minimum of 1 to a maximum of 5. Higher scores indicating greater resilience.
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Social Isolation
The 10-item Lubben Social Network Scale assesses objective size of social network. Items are rated on a 6 point scale. Sum scores are calculated. Possible scores range from a minimum of 0 and maximum of 60. Higher scores indicate larger social network and contacts.
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Self-reported loneliness
The 3-item UCLA Loneliness scale assesses the feeling of being alone or lacking companionship. Responses range from 1 to 3. Sum scores are calculated. Possible scores range from a minimum of 3 to a maximum of 9. Higher numbers indicate greater perceived loneliness.
Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Depression
Participants will complete the 15-item Geriatric Depression Scale. The items include yes/no responses. Scores will be summed. Possible scores range from a minimum value of 0 to a maximum value of 15. Higher scores indicate greater depression. At eligibility screening, participants must score below 9 on this measure to be included in the study.
Time frame: Assessed at screening and after the 3 month intervention
General Anxiety
Participants will complete the 7-item General Anxiety Disorder Questionnaire. Using a 4 point scale (0 to 3), the items assess worry and anxiety over the past two weeks. Mean scores will be calculated. Possible scores range from a minimum score of 0 to a maximum score of 21. Higher scores indicate greater anxiety.
Time frame: Assessed at baseline and after the 3 month intervention
Health-related quality of life
Participants will complete the 4-item health-related quality of life assessment. The items assess self-perceived health and days during the past month they had poor physical health or mental health, and the extent to which poor health kept them from doing daily activities. Mean scores will be calculated. Higher scores indicate poorer health-related quality of life.
Time frame: Assessed at baseline and after the 3 month intervention
Cognitive Health
To establish eligibility, participants will complete the Telephone administered Montreal Cognitive Assessment (T-MoCA) during the online eligibility screening. Because we are recruiting individuals with subjective cognitive decline, we will rule out potential cognitive impairment with the T-MoCA. Scores are totaled. Possible scores range from 0 to 22. Higher scores indicating better performance. Participants scoring 17 or lower (out of 22) will be ineligible for participation. We will readminister at the end of the 3 month intervention to determine whether change occurred.
Time frame: Assessed during online eligibility screening and after the 3 month intervention
Change in Garmin-assessed physical activity
Participants agree to wear a Garmin throughout the study, offering continuous data about their physical activity. We will use average daily steps (calculated weekly, from Monday to Sunday) to assess physical activity continuously during the intervention.
Time frame: From enrollment to the end of treatment at 3 months
Subjective Cognitive Decline
Participants will complete the 20-item Subjective Cognitive Decline questionnaire. They will rate the level of change on a 5 point scale (no change to much worse). Mean scores will be calculated, with higher scores indicating greater perceived decline in cognitive functioning.
Time frame: Assessed at baseline and after the 3 month intervention
Objective cognitive functioning: Processing Speed 2
Participants will complete two tasks assessing processing speed. The second requires matching of patterns between numbers and symbols as quickly as possible without making mistakes. This is the Oral Symbol Digit Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Time frame: Assessed at baseline and after the 3 month intervention
Objective cognitive functioning: Processing Speed 1
Participants will complete two tasks assessing processing speed. The first requires visual processing of patterns in two pictures, detecting similarities and differences as quickly as possible without making mistakes. This is the Pattern Comparison Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Time frame: Assessed at baseline and after the 3 month intervention
Objective cognitive functioning: Executive functioning
Participants will complete an executive functioning task requiring set-shifting, or the ability to switch back and forth between multiple aspects of a strategy or task. This is the Dimensional Change Card Sort Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Time frame: Assessed at baseline and after the 3 month intervention
Objective cognitive functioning: Verbal memory
Participants will complete a verbal memory task in which they hear a series of words read and are asked to recall as many as they can immediately after the list; this process is completed three times total to assess both learning and memory. Ten to 15 minutes later, they are asked to recall as many words as possible. This is the Auditory Verbal Learning Test from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Time frame: Assessed at baseline and after the 3 month intervention
Objective cognitive functioning: Visual memory
Participants will complete a visual memory task in which they see a series of pictures in a specified order. Immediately after, they are tasked with placing the pictures in the correct order. This is the Picture Sequence Memory Test from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Time frame: Assessed at baseline and after the 3 month intervention
Protocol Adherence
To assess protocol adherence, we will calculate number of days the Garmin is worn (all participants), the number of weeks participants met their physical activity goal (all participants), and the number of coaching sessions attended (participants in the tech enhanced group only). Higher numbers for each indicate greater levels of adherence to the protocol.
Time frame: Assessed after the 3 month intervention is complete
Treatment Acceptance
To assess overall acceptability of the intervention, participants will complete a treatment acceptance survey specifically adapted for this study. This survey will include satisfaction and acceptability ratings, as well as open-ended questions to obtain participant feedback. Total scores are not calculated. This data will be used to improve the intervention for future studies.
Time frame: Assessed after the 3 month intervention is complete
Started Jun 2025 (actual). Primary completion is estimated for Mar 2027, 21 months after the start.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 21 months is above that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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