Recruiting

Physical Activity

Sponsor:

Arizona State University

Code:

NCT05980052

Conditions

Physical Activity

Exercise

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

Interventions

Physical Activity

Study Details

Brief summary:

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

Conditions

Physical Activity

Exercise

Study ID

NCT05980052

Start date

Jul 17, 2023

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Static weekly physical activity goal of 150 minutes/week

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.

experimental: Incremental weekly physical activity goal increase

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.

experimental: Self-selected weekly physical activity goal

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.

experimental: No stated weekly physical activity goal (comparison group)

Participants will receive a physical activity action planning intervention that does not include explicitly stated physical activity goals to achieve.

Interventions

Physical Activity

Theory-driven behavioral physical activity promotion intervention.

Primary outcome measure

  • 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 ]
  • Change in Fitbit-assessed moderate-to-vigorous intensity physical activity [ Time Frame: Assessed daily up to 9-months ]
  • 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 ]

Central Contacts and Locations

Central contacts

Rodney Joseph, PhD

602-496-0772rodney.joseph@asu.edu

Molly Maxfield, PhD

602-496-2311molly.maxfield@asu.edu

Locations

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Rodney P Joseph

602-496-0772rodney.joseph@asu.edu

Principal Investigator:

Rodney P Joseph, PhD

More Information

Sponsor

Arizona State University

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • exercise
  • physical activity
  • mild cognitive impairment
  • Alzheimer's disease
  • dementia
  • behavior change
  • midlife

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-07-17.