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Search / Trial NCT05826379

Daily Goal Setting to Increase Everyday Physical Activity and Promote Cognitive Health in Midlife

Launched by MILTON S. HERSHEY MEDICAL CENTER · Apr 11, 2023

Trial Information

Current as of August 20, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

The study is designed to examine the efficacy of a Fitbit-based, goal setting, mHealth intervention to increase light intensity physical activity. The study design is a 2-arm randomized controlled trial. Both groups will receive the underlying goal-setting intervention (adaptive daily step goals). The study involves 3 phases: a run-in ("calibration") phase, the intervention ("training") phase, and follow-up (1- and 12-months post-intervention).

To support goal maintenance our team has developed a Fitbit application designed to operate on the Fitbit Versa series watch as a 'clockface'. The ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria\*:
  • Between 30 and 70 years of age
  • BMI ≥ 25
  • Exclusion Criteria\*:
  • Clinical diagnosis of ADRD or other neurodegenerative disease
  • Health condition contraindicated for increased physical activity
  • Medical conditions or medications that would prohibit participation in an exercise test (e.g., decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndromes)
  • Limitations in use of a smart phone (e.g., issues with manual dexterity or visual impairment)
  • Inability to walk unassisted
  • BMI \> 50
  • Plan to have surgery or other procedure over the next 12 months that could affect mobility or light intensity physical activity maintenance
  • Concurrent participation in a weight loss, physical activity, or cognitive training trial
  • Failure to comply with Run-in Period activity monitoring (\<70% valid wear days for the Fitbit and activPal)
  • Anyone who will not discontinue the use of their own personal smartwatch during the training period.
  • Anyone who scores below 19 on the MoCA-B would not be randomized after the Run-in Calibration Period.
  • Note: The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study. These details will be added after study closure.

About Milton S. Hershey Medical Center

Milton S. Hershey Medical Center, a leading academic medical institution affiliated with Penn State University, is dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the center leverages its expertise in various medical fields to conduct rigorous clinical studies aimed at improving treatment outcomes and enhancing the understanding of complex health conditions. The facility is committed to ethical research practices and fostering collaboration among multidisciplinary teams, ensuring that participants receive the highest standard of care while contributing to the advancement of medical knowledge.

Locations

Hershey, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Jonathan G Hakun, PhD

Principal Investigator

Milton S. Hershey Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported