Goal Setting to Promote Physical Activity Adherence in Midlife Adults
Recruiting · NCT05980052 · Interventional (participants receive a specific treatment) · Lead sponsor: Arizona State University
View the official record on ClinicalTrials.gov →Interventions studied
Physical Activity
What this trial is about
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
Who can take part
Age range
45 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed across 1 US state.
- Arizona State University - Phoenix, Arizona, United States