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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ways to set goals that help adults ages 45 to 65 become more active and stick with activity guidelines. It is for adults who do little physical activity and meet the study’s weight requirements. The long-term goal is to lower the risk of Alzheimer’s disease and related memory conditions.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 45 to 65 years old.
  • Your body mass index (BMI), a measure based on height and weight, is 30 to 50.
  • You weigh at least 110 pounds.
  • At screening, you report 60 minutes or less of activity that makes you breathe harder, based on an exercise questionnaire.
  • You own an iPhone or Android smartphone to track activity with a Fitbit.

Who can't join

  • You answer yes to an item on an exercise safety questionnaire, or your resting blood pressure is above 200/110 at the first study visit, unless you provide a doctor’s note.
  • You are pregnant or plan to become pregnant within 8 months for Phase 1 or 12 months for Phase 2.
  • You plan to move out of the Phoenix, Arizona, metro area within 8 months for Phase 1 or 12 months for Phase 2.
  • You take part in another exercise, nutrition, or weight-loss program at screening or during this study.
  • You have mild cognitive impairment, meaning mild problems with memory or thinking, based on a reported diagnosis or the MoCA thinking test. Excluded scores are below 26 for people born in the U.S., or below 23 for people born outside the U.S. who finished high school in a country where English is not the main language.
  • You have ever been prescribed donepezil, rivastigmine, galantamine, memantine, or memantine plus donepezil for Alzheimer’s disease.
  • You score 16 or higher on the CES-D depression questionnaire, report a current diagnosis of major depression, or currently take 2 or more antidepressant medicines.
  • You have had a stroke or are in prison.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

AZ