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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 November 06, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This study tests whether a Fitbit-based goal-setting app can help adults who are middle-aged or older increase their everyday light physical activity. It’s a two-group, randomized trial where everyone gets adaptive daily step goals, but the treatment group also gets short-term prompts each day. The study has three parts: a 14-day calibration period to learn each person’s usual activity, a 1-month training period where goals are shown on a Fitbit clockface, and follow-up checks about 1 month and 12 months after training. Researchers will track steps with Fitbit and a small activity monitor (activPAL) and will collect brief cognitive tests and self-care surveys through a smartphone-based platform.

Who can join? Adults aged 30–70 with a body mass index (BMI) of 25 or higher (overweight or obese) who are generally healthy and can safely increase activity. Exclusions include a clinical diagnosis of Alzheimer’s or other neurodegenerative diseases, health conditions that would make more activity unsafe, certain medical issues that prevent a safe exercise test, the inability to walk without help, BMI over 50, plans for procedures over the next year, or not able to wear the devices or use a smartphone. The study is based at Milton S. Hershey Medical Center in Hershey, Pennsylvania, and aims to enroll about 200 people. It is not a drug or medical-device trial, and results are not yet available.

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