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| ID | Type | Description | Link |
|---|---|---|---|
| R61AG078089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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
More than 6 million U.S. adults live with diagnoses of Alzheimer's Disease and Related Dementias (AD/ADRD), with projections as high as 13.8 million cases by 2050. There are no cures for AD/ADRD, making lifestyle factors key targets for reducing risk, as they account for at least a third of AD/ADRD cases. Engaging in regular physical activity (PA), particularly in midlife, is associated with reduced risk for AD/ADRD. Yet, nearly half of midlife adults (48%) do not meet national PA guidelines of 150 minutes/week of moderate-intensity PA. Goal setting is a commonly used behavior change strategy to increase PA. Key psychosocial mechanisms believed to underpin the use of goal setting to promote PA include self-regulation and self-efficacy. However, the most effective goal setting technique to enhance these psychosocial mechanisms for the successful promotion of PA and adherence to national PA guidelines remains unclear. In the proposed study, the investigators will use a two-phased approach to empirically test three goal setting techniques to enhance psychosocial mechanisms of self-regulation and self-efficacy for the successful promotion of PA and adherence to national PA guidelines among insufficiently active midlife adults with obesity. In the R61 phase, a Phase 1 pilot study will establish feasibility and help refine the intervention. In the R33 phase, a Phase 2 9-month 4-arm proof-of-concept mechanistic trial (6-month active intervention and 3-month no contact follow-up) will be implemented to establish preliminary efficacy of goal setting techniques to increase PA and promote adherence to national PA guidelines. All participants will receive a Fitbit to self-monitor PA and engage in PA action planning sessions with a study interventionist. In addition, participants will be randomly assigned to 1 of 4 groups: i) static weekly goal of 150 minutes/week of moderate-intensity PA, which most closely resembles the approach of public health campaigns and care providers; ii) weekly self-selected PA goals, which allows for self-determination and adaptation of the goal; iii) modest incremental weekly PA increase goal (i.e., researcher determined PA goal that 20% minutes/week greater than the minutes/week of PA in the previous week); or iv) non-goal setting control group. Based on Goal Setting Theory, it is hypothesized that participants in the incremental goal group will have the greatest increases in self-regulation and self-efficacy, which in turn, will lead to the greatest improvements in PA and adherence to national PA guidelines over the 9-month intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Static weekly physical activity goal of 150 minutes/week | Experimental | Participants will receive a physical activity action planning intervention and assigned a static weekly physical activity goal of 150 minutes/week of moderate-intensity activity; action planning sessions will focus on the participant achieving this weekly goal. |
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| Incremental weekly physical activity goal increase | Experimental | Participants will receive a physical activity action planning intervention and assigned a weekly physical activity goal that is 20% greater than the level of moderate-intensity physical activity performed the previous week; action planning sessions will focus on the participant achieving their assigned goal. |
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| Self-selected weekly physical activity goal | Experimental | Participants will receive a physical activity action planning intervention and will self-select their own moderate-intensity physical activity goal each week; action planning sessions will focus on helping participants achieve their self-selected goal. |
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| No stated weekly physical activity goal (comparison group) | Experimental | Participants will receive a physical activity action planning intervention that does not include explicitly stated physical activity goals to achieve. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Behavioral | Theory-driven behavioral physical activity promotion intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at baseline, 6-months, 9-months |
| 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. | Assessed daily up to 9-months |
| 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. | Assessed at baseline, 6-months, 9-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodney Joseph, PhD | Contact | 602-496-0772 | rodney.joseph@asu.edu | |
| Molly Maxfield, PhD | Contact | 602-496-2311 | molly.maxfield@asu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Recruiting | Phoenix | Arizona | 85004 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Four arm randomized mechanistic proof-of-concept trial
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| Assessed monthly up to 9-months |
| 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. | Assessed monthly up to 9-months |
| 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. | Assessed monthly up to 9-months |
| 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 | Assessed monthly up to 9-months |
| Change in General Self-Efficacy from baseline to 6- and 9-months | Assessed using the 10-item Self-Efficacy Scale publicly available in SOBC repository & NIH Toolbox. The range of possible scores is 31 to 155. Higher scores indicate greater self-efficacy. | Assessed monthly up to 9-months |
| Assessed at baseline, 6-months, 9-months |
| 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. | Assessed at baseline, 6-months, 9-months |
| 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. | Assessed at baseline, 6-months, 9-months |
| 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. | Assessed at baseline, 6-months, 9-months |
| Change in pattern comparison processing speed from baseline to 6- and 9-months | Assessed using the Pattern Comparison Processing Speed Test. This test asks participants to determine whether two stimuli are the same or not the same as quickly as possible without making mistakes. It 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. | Assessed at baseline, 6-months, 9-months |
| Change in processing speed from baseline to 6- and 9-months | Assessed using the Oral Symbol Digit Test. This test assesses time needed to process pairings of digits & symbols and 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. | Assessed at baseline, 6-months, 9-months |
| Change in plasma amyloid 42/40 ratio from baseline to 6- and 9-months | Assessed using commercial Meso Scale Discovery (MSD) assays | Assessed at baseline, 6-months, 9-months |
| Change in plasma phosphorylated tau 231 from baseline to 6- and 9-months | Assessed using commercial Meso Scale Discovery (MSD) assays | Assessed at baseline, 6-months, 9-months |
| Adjudication for Mild Cognitive Impairment (MCI) | Investigator-consensus adjudication will be performed by three investigators to determine if a participant has diagnosable MCI according to the NIA-AA guidelines (Albert et al., 20211). | Performed using data collected at 6-months and 9-months |
| Change in body weight from baseline to 6- and 9-months | Measured in kilograms using an electronic scale | Assessed at baseline, 6-months, 9-months |
| Change in BMI from baseline to 6- and 9-months | Calculated using the formula: weight (in kilograms) / height (in meters)^squared | Assessed at baseline, 6-months, 9-months |
| Change in blood pressure (mmHG) from baseline to 6- and 9-months | Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest | Assessed at baseline, 6-months, 9-months |
| Change in fasting plasma glucose (mg/dL) from baseline to 6- and 9-months | Assessed using an automated chemistry analyzer | baseline, 6-months, 9-months |
| Change in serum lipids (mg/DL) from baseline to 6- and 9-months | Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed | Assessed at baseline, 6-months, 9-months |
| Change in insulin sensitivity (µIU/mL) from baseline to 6- and 9-months | Calculated using homeostatic model assessment (HOMA) | Assessed at baseline, 6-months, 9-months |
| Change in depressive symptoms from baseline to 6- and 9-months | Assessed using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977). This scale has a possible score range 0 to 60, with higher scores indicating greater frequency of depressive symptoms. | Assessed at baseline, 6-months, 9-months |
| Protocol Adherence | Number of days Fitbit worn, number of days Fitbit synced, number of weeks study arm specific PA goal met, and number of individual coaching meetings attended. | Assessed at 6-months and 9-months |
| Treatment acceptance | Survey assessing acceptance, feasibility, and consumer satisfaction of intervention. | Assessed at 6-months and 9-months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |