Arizona State University
Phoenix, Arizona, 85004, United States
Location status: Recruiting
Location contact
Molly Maxfield, PhD
PRINCIPAL_INVESTIGATOR
Rodney P Joseph
CONTACT
Rodney P Joseph, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05980052
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
Interested in participating?
Request Info45 year–65 year
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85004, United States
Location status: Recruiting
Molly Maxfield, PhD
PRINCIPAL_INVESTIGATOR
Rodney P Joseph
CONTACT
Rodney P Joseph, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Theory-driven behavioral physical activity promotion intervention.
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed daily up to 9-months
Participants will wear a wrist-worn Fitbit activity monitor daily throughout the 9-month intervention.
Time frame: Assessed at baseline, 6-months, 9-months
Self-reported minutes per week of moderate-to-vigorous physical activity assessed by the 7-day Physical Activity Recall.
Time frame: Assessed monthly up to 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.
Time frame: Assessed monthly up to 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.
Time frame: Assessed monthly up to 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.
Time frame: Assessed monthly up to 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
Time frame: Assessed monthly up to 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.
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed at baseline, 6-months, 9-months
Assessed using commercial Meso Scale Discovery (MSD) assays
Time frame: Assessed at baseline, 6-months, 9-months
Assessed using commercial Meso Scale Discovery (MSD) assays
Time frame: Performed using data collected at 6-months and 9-months
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).
Time frame: Assessed at baseline, 6-months, 9-months
Measured in kilograms using an electronic scale
Time frame: Assessed at baseline, 6-months, 9-months
Calculated using the formula: weight (in kilograms) / height (in meters)^squared
Time frame: Assessed at baseline, 6-months, 9-months
Both systolic and diastolic blood pressure will be assessed using electronic sphygmomanometer following 5-min rest
Time frame: baseline, 6-months, 9-months
Assessed using an automated chemistry analyzer
Time frame: Assessed at baseline, 6-months, 9-months
Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed
Time frame: Assessed at baseline, 6-months, 9-months
Calculated using homeostatic model assessment (HOMA)
Time frame: Assessed at baseline, 6-months, 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.
Time frame: Assessed at 6-months and 9-months
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.
Time frame: Assessed at 6-months and 9-months
Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.
Contact information is provided by the study sponsor or research team.
Molly Maxfield, PhD
CONTACT
Rodney Joseph, PhD
CONTACT
Arizona State University
Other
Goal Setting to Promote Physical Activity Adherence in Midlife to Reduce Risk of Alzheimer's Disease and Related-Dementias: A Randomized Mechanistic Proof-Of-Concept Trial
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