Goal setting to increase physical activity 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
This study is testing different goal-setting methods to help midlife adults with obesity become more active and reduce their risk of Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT05980052 on ClinicalTrials.gov |
What this trial studies
This trial aims to enhance physical activity adherence among midlife adults by testing various goal-setting techniques. It focuses on individuals aged 45 to 65 with obesity who currently engage in minimal physical activity. The study will employ a two-phased approach, starting with a pilot phase to establish feasibility, followed by a proof-of-concept trial to evaluate the effectiveness of the interventions over nine months. The ultimate goal is to promote regular physical activity to reduce the risk of Alzheimer's disease and related dementias.
Who should consider this trial
Good fit: Ideal candidates are midlife adults aged 45 to 65 with a BMI between 30 and 50 who engage in less than 60 minutes of moderate-to-vigorous physical activity per week.
Not a fit: Patients with significant health issues that prevent them from engaging in physical activity or those who are already meeting physical activity guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical activity levels in midlife adults, potentially reducing their risk of Alzheimer's disease and related dementias.
How similar studies have performed: Other studies have shown promise in using goal-setting techniques to enhance physical activity adherence, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Phoenix, Arizona
- Arizona State University — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Rodney Joseph, PhD
- Email: rodney.joseph@asu.edu
- Phone: 602-496-0772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.