RecruitingNot ApplicableNCT05980052

Goal Setting to Promote Physical Activity Adherence in Midlife Adults

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


Sponsor

Arizona State University

Enrollment

144 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 45 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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)

Interventions

BEHAVIORALPhysical Activity

Theory-driven behavioral physical activity promotion intervention.


Locations(1)

Arizona State University

Phoenix, Arizona, United States

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NCT05980052


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