ClinConnect ClinConnect Logo
Search / Trial NCT05980052

Goal Setting to Promote Physical Activity Adherence in Midlife Adults

Launched by ARIZONA STATE UNIVERSITY · Aug 3, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Exercise Physical Activity Mild Cognitive Impairment Alzheimer's Disease Dementia Behavior Change Midlife

ClinConnect Summary

This clinical trial is investigating how setting specific goals can help midlife adults become more physically active. Regular exercise is important for reducing the risk of Alzheimer’s disease and related conditions, but many adults in this age group aren’t meeting the recommended activity levels. The trial aims to find effective ways to encourage individuals aged 45 to 65, who have a higher body weight (BMI between 30 to 50), to increase their physical activity through goal-setting techniques. Participants will need to use a smartphone and a Fitbit device to track their activities.

To join the study, you should be between 45 and 65 years old, with a body weight of at least 110 pounds, and engage in no more than 60 minutes of moderate to vigorous physical activity per week. However, there are some exclusions, such as having certain health conditions or being pregnant. If you qualify and decide to participate, you can expect to work on setting personal activity goals, receive support throughout the process, and contribute to important research aimed at improving health and reducing the risk of Alzheimer’s.

Gender

ALL

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)

About Arizona State University

Arizona State University (ASU) is a leading research institution dedicated to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, ASU leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical research aimed at improving patient outcomes and contributing to the scientific community. With a commitment to ethical research practices and collaboration with healthcare professionals, ASU strives to translate research findings into practical applications that benefit society. The university's focus on community engagement and real-world impact underscores its role as a pivotal player in the advancement of clinical research.

Locations

Phoenix, Arizona, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported