About this trial
Engaging in regular physical activity during midlife is a key lifestyle behavior associated with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of midlife adults (48%) do not meet national physical activity guidelines. The purpose of this mechanistic trial is to identify effective goal setting techniques to enhance psychosocial processes of self-regulation for the successful promotion of PA and adherence to national PA guidelines among midlife adults, with the long-term goal of reducing AD/ADRD risk
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 45 to 65 years
BMI between 30 kg/m2 to 50 kg/m2
Participants must weigh a minimum of 110 pounds
Engaging in 60 minutes or less of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
Disqualifiers
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)
Pregnant or planning to become pregnant in next 8-months (Phase 1) or 12 months (Phase 2)
Plans to relocate out of metropolitan Phoenix, Arizona area in the next 8-months (Phase 1) or 12 months (Phase 2)
Trial design
Parallel
Treatments tested in this trial
Physical Activity
BehavioralTheory-driven behavioral physical activity promotion intervention.
Treatment groups
Trial outcomes
Primary outcomes
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity.
Change in Fitbit-assessed moderate-to-vigorous intensity physical activity
Participants will wear a wrist-worn Fitbit activity monitor daily throughout the 9-month intervention.
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months
Self-reported minutes per week of moderate-to-vigorous physical activity assessed by the 7-day Physical Activity Recall.
Secondary outcomes
Change in physical activity self-regulation from baseline to 6- and 9-months
Assessed using the The 12-item Physical Activity Self-Regulation Scale (PASR-12; Umstattd et al., 2009). This scale assess 6 PA-related self-regulatory domains: self-monitoring, goal setting, eliciting social support, reinforcements, time management, relapse prevention. The range of possible scores is 5-60, with higher scores indicating higher levels of physical activity self-regulation.
Change in physical activity behavioral strategies from baseline to 6- and 9-months
Assessed using 10-item Self-Regulation scale from the Health Belief Survey (Anderson et al., 2010) This scale assesses the use of behavioral strategies to incorporate physical activity into daily activities (i.e., take stairs instead of elevator, walking instead of driving when running errands). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-regulation.
Change in physical activity self-efficacy from baseline to 6- and 9-months
Assessed by the 12-item Exercise Self-Efficacy survey (Sallis et al.1987). The range of possible scores for this measure is 1-5, with higher scores indicating higher levels of physical activity self-efficacy.
Change in general self-regulation from baseline to 6- and 9-months
Assessed using the 31-item short version of the self-regulation scale (SSRS; Carey, Neal, \& Collins, 2004). The range of possible scores is 31 to 155, with higher scores indicate greater self-regulation
Other outcomes
Change in immediate verbal memory from baseline to 6- and 9-months
Assessed using the Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in delayed verbal memory from baseline to 6- and 9-months
Assessed using the Delayed Auditory Verbal Learning Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in visual memory from baseline to 6- and 9-months
Assessed using the Picture Sequence Memory Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Change in executive function from baseline to 6- and 9-months
Assessed using the Dimensional Change Card Sort Test. This test is administered on an iPad and is scored automatically using software available from the NIH Toolbox, which provides an age-adjusted standard score (possible range: 50 to 150) and percentile score (possible range: 1st percentile to 99th percentile). Higher scores indicate greater immediate verbal memory capacity.
Sponsors and contacts
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Arizona State University
Lead sponsor
National Institute on Aging (NIA)
Collaborator