Status:
RECRUITING
Goal Setting to Promote Physical Activity Adherence in Midlife Adults
Lead Sponsor:
Arizona State University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Physical Activity
Exercise
Eligibility:
All Genders
45-65 years
Phase:
NA
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...
Detailed Description
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, maki...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05980052
Start Date
July 17 2023
End Date
December 31 2026
Last Update
July 17 2025
Active Locations (1)
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1
Arizona State University
Phoenix, Arizona, United States, 85004