NCT05826379

Brief Summary

The purpose of this study is to determine whether interaction with an adaptive Fitbit-based goal setting application can increase levels of everyday light intensity physical activity in middle-aged adults.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Mar 2024Jul 2027

First Submitted

Initial submission to the registry

March 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

March 15, 2023

Last Update Submit

May 5, 2025

Conditions

Physical InactivityWalkingCognitive HealthSelf-regulationOverweight and Obesity

Outcome Measures

Primary Outcomes (2)

  • Short-term adherence

    Average of 14-day step count totals collected via ActivPal monitors

    1-month follow-up

  • Long-term adherence

    Average of 14-day step count totals collected via ActivPal monitors

    12-month follow-up

Secondary Outcomes (6)

  • Self-Monitoring Behavior

    Daily during intervention period

  • Change in Cognitive Health (Processing Speed)

    Change in mean performance between the 2-week calibration phase and 12-month follow-up

  • Change in Cognitive Health (Working Memory Binding)

    Change in mean performance between the 2-week calibration phase and 12-month follow-up

  • Change in Self-Efficacy for light intensity physical activity

    Change between pre-enrollment baseline survey and end of training phase (an average of 2 months)

  • Executive Control (Working Memory Capacity)

    Twice daily during the final 2 weeks of the training phase

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants receive the adaptive daily step goal mHealth intervention

Behavioral: Adaptive Daily Goal Setting

Treatment

EXPERIMENTAL

Participants receive the adaptive daily step goal mHealth intervention plus interim goal setting prompts each day

Behavioral: Adaptive Daily Goal SettingBehavioral: Interim Goal Prompt

Interventions

Adaptive Daily Goal SettingBEHAVIORAL

Daily step goals displayed by the study application

ControlTreatment
Interim Goal PromptBEHAVIORAL

Short-term step goals

Treatment

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 30 and 70 years of age
  • BMI ≥ 25

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorSelf-ControlOverweightObesity

Condition Hierarchy (Ancestors)

BehaviorSocial BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan G Hakun, PhD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology, Psychology, & Public Health Sciences

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 24, 2023

Study Start

March 20, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

May 8, 2025

Record last verified: 2025-05

Locations

US(1)