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

Overweight and Obesity Clinical Trial

Official title:

Mechanisms of Adherence to Light Intensity Physical Activity to Prevent Alzheimer's Disease and Related Dementias (ADRD)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05826379
• Other study ID #: STUDY00022087
• Secondary ID: R61AG078084
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 application will first calibrate participants' average level of physical activity by recording daily step counts for a period of 14 days (calibration phase). After this period (and following a health education session) the application will begin delivering the underlying intervention to both treatment and control groups for a period of 1 month. The intervention is composed of daily step goals presented via the Fitbit clockface. Each day the application will suggest a daily step goal. The algorithm used to make these suggestions relies on the participant's own activity during the calibration period and is updated each day in study, ensuring all proposed step goals are within their existing repertoire. Follow-up assessments will be completed at 1- and 12-monts post-intervention.

Outcomes and moderators will be measured via activity monitors (the Fitbit application and activPals), surveys, and ecological momentary assessments (self-ratings and performance-based ambulatory cognitive assessments) conducted via the Mobile Monitoring of Cognitive Change ("M2C2") platform.

Some of the details of the intervention, algorithm, experimental manipulations, and outcomes have been omitted to preserve the scientific integrity of the study. These details will be added after the study is closed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 1, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Health
• Overweight
• Overweight and Obesity
• Physical Inactivity
• Self-regulation
• Walking

Intervention

Behavioral:
• Adaptive Daily Goal Setting
Daily step goals displayed by the study application
• Interim Goal Prompt
Short-term step goals

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term adherence	Average of 14-day step count totals collected via ActivPal monitors	1-month follow-up
Primary	Long-term adherence	Average of 14-day step count totals collected via ActivPal monitors	12-month follow-up
Secondary	Self-Monitoring Behavior	Number of times participant checks their step count progress per day	Daily during intervention period
Secondary	Change in Cognitive Health (Processing Speed)	Change in performance on ambulatory cognitive assessments of processing speed (response time during the "Symbol Search" task). This task is administered twice daily (2 "sessions" per day) throughout the 2-week, baseline "calibration phase" and twice daily throughout the 2-week, 12-month follow-up phase. The outcome to be modeled is median response time to trials administered during each session. Aggregation of data collected over these 2-week data collection periods will be model-based (in other words, all 'session' data will be modeled nested within phase, within persons).	Change in mean performance between the 2-week calibration phase and 12-month follow-up
Secondary	Change in Cognitive Health (Working Memory Binding)	Change in performance on ambulatory cognitive assessments of working memory binding (corrected recognition rate during the "Color Shapes" task). This task is administered twice daily (2 "sessions" per day) throughout the 2-week, baseline "calibration phase" and twice daily throughout the 2-week, 12-month follow-up phase. The outcome to be modeled is corrected recognition rate (hit rate minus false alarm rate) for trials administered during each session. Aggregation of data collected over these 2-week data collection periods will be model-based (in other words, all 'session' data will be modeled nested within phase, within persons).	Change in mean performance between the 2-week calibration phase and 12-month follow-up
Secondary	Change in Self-Efficacy for light intensity physical activity	Self-efficacy for exercise scale (adapted to light intensity physical activity; range 0-90 points; higher scores reflect better outcomes)	Change between pre-enrollment baseline survey and end of training phase (an average of 2 months)
Secondary	Executive Control (Working Memory Capacity)	Performance on ambulatory cognitive assessments of working memory capacity (span score during the "Rotation Span" task). This task is administered twice daily (2 "sessions" per day) during the last 2 weeks of the "training phase". The outcome to be modeled is the total recalled arrows across the 3 trials assessed during each session. Data will not be aggregated, but instead modeled as a time-varying covariate.	Twice daily during the final 2 weeks of the training phase
Secondary	Executive Control (Inhibitory Control)	Performance on ambulatory cognitive assessments of inhibitory control (commission errors during the "Go/NoGo" task). This task is administered twice daily (2 "sessions" per day) during the last 2 weeks of the "training phase". The outcome to be modeled is the total commission errors across the trials assessed during each session. Data will not be aggregated, but instead modeled as a time-varying covariate.	Twice daily during the final 2 weeks of the training phase