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NCT Number: NCT05980052

Goal Setting to Promote Physical Activity Adherence in Midlife Adults

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

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

Location status: Recruiting

Location contact

Molly Maxfield, PhD

PRINCIPAL_INVESTIGATOR

Rodney P Joseph

CONTACT

[email protected]

602-496-0772

Rodney P Joseph, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Self-reported ownership of a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a Fitbit activity monitor)

Exclusion criteria

  • 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)
  • Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
  • Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Montreal Cognitive Assessment (MoCA) at the study orientation session. A score < 26 is an exclusion criterion for US born participants. A score of <23 is an exclusion for participants born outside of the US who completed their high school education in a country where English is not the primary language.
  • 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 16 or higher on the Center for Epidemiological Studies-Depression Scale (CES-D)
  • Self-reported current diagnosis of major depression
  • Currently taking 2 or more ant-depression drugs
  • History of stroke
  • Incarcerated individuals (i.e., Prisoners)

Treatment and study plan

Physical activity

Behavioral

Theory-driven behavioral physical activity promotion intervention.

Primary outcomes

  1. Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months

    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.

  2. Change in Fitbit-assessed moderate-to-vigorous intensity physical activity

    Time frame: Assessed daily up to 9-months

    Participants will wear a wrist-worn Fitbit activity monitor daily throughout the 9-month intervention.

  3. Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 6- and 9-months

    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.

Secondary outcomes

  1. Change in physical activity self-regulation from baseline to 6- and 9-months

    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.

  2. Change in physical activity behavioral strategies from baseline to 6- and 9-months

    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.

  3. Change in physical activity self-efficacy from baseline to 6- and 9-months

    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.

  4. Change in general self-regulation from baseline to 6- and 9-months

    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

  5. Change in General Self-Efficacy from baseline to 6- and 9-months

    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.

Other outcomes

  1. Change in immediate verbal memory from baseline to 6- and 9-months

    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.

  2. Change in delayed verbal memory from baseline to 6- and 9-months

    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.

  3. Change in visual memory from baseline to 6- and 9-months

    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.

  4. Change in executive function from baseline to 6- and 9-months

    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.

  5. Change in pattern comparison processing speed from baseline to 6- and 9-months

    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.

  6. Change in processing speed from baseline to 6- and 9-months

    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.

  7. Change in plasma amyloid 42/40 ratio from baseline to 6- and 9-months

    Time frame: Assessed at baseline, 6-months, 9-months

    Assessed using commercial Meso Scale Discovery (MSD) assays

  8. Change in plasma phosphorylated tau 231 from baseline to 6- and 9-months

    Time frame: Assessed at baseline, 6-months, 9-months

    Assessed using commercial Meso Scale Discovery (MSD) assays

  9. Adjudication for Mild Cognitive Impairment (MCI)

    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).

  10. Change in body weight from baseline to 6- and 9-months

    Time frame: Assessed at baseline, 6-months, 9-months

    Measured in kilograms using an electronic scale

  11. Change in BMI from baseline to 6- and 9-months

    Time frame: Assessed at baseline, 6-months, 9-months

    Calculated using the formula: weight (in kilograms) / height (in meters)^squared

  12. Change in blood pressure (mmHG) from baseline to 6- and 9-months

    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

  13. Change in fasting plasma glucose (mg/dL) from baseline to 6- and 9-months

    Time frame: baseline, 6-months, 9-months

    Assessed using an automated chemistry analyzer

  14. Change in serum lipids (mg/DL) from baseline to 6- and 9-months

    Time frame: Assessed at baseline, 6-months, 9-months

    Triglycerides, total cholesterol, LDL-C, and HDL-C will be assessed

  15. Change in insulin sensitivity (µIU/mL) from baseline to 6- and 9-months

    Time frame: Assessed at baseline, 6-months, 9-months

    Calculated using homeostatic model assessment (HOMA)

  16. Change in depressive symptoms from baseline to 6- and 9-months

    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.

  17. Protocol Adherence

    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.

  18. Treatment acceptance

    Time frame: Assessed at 6-months and 9-months

    Survey assessing acceptance, feasibility, and consumer satisfaction of intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Molly Maxfield, PhD

CONTACT

[email protected]

602-496-2311

Rodney Joseph, PhD

CONTACT

[email protected]

602-496-0772

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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