Daily Goal Setting for Cognitive Health

Overseen By Jessie Research Project Manager, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Neurodegenerative disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your medications prohibit participation in an exercise test, you may not be eligible for the trial.

What data supports the effectiveness of the treatment Adaptive Daily Goal Setting, Interim Goal Prompt for cognitive health?

Research shows that setting specific and high goals can improve performance in brain-damaged patients, suggesting that goal setting can be a powerful motivational tool to enhance cognitive function. ^{1 2 3 4 5}

Is daily goal setting safe for humans?

The studies reviewed do not provide specific safety data for daily goal setting interventions, but they do not report any safety concerns or adverse effects in participants with traumatic brain injury or other conditions. ^{3 4 6 7 8}

How does the treatment Adaptive Daily Goal Setting differ from other treatments for cognitive health?

Adaptive Daily Goal Setting is unique because it focuses on training individuals to use self-regulatory strategies to manage and achieve daily goals, which helps compensate for age-related cognitive changes. This approach is different from traditional memory training as it emphasizes practical application in everyday life rather than just improving performance on memory tests. ^{9 10 11 12 13}

Research Team

Jonathan G Hakun, PhD

Principal Investigator

Milton S. Hershey Medical Center

Eligibility Criteria

This trial is for middle-aged adults aged between 30 and 70 with a BMI of at least 25, who can walk unassisted. It's not suitable for those with severe obesity (BMI over 50), neurodegenerative diseases, conditions that limit exercise, or visual/manual impairments affecting smartphone use.

Inclusion Criteria

I am between 30 and 70 years old.

BMI ≥ 25

Exclusion Criteria

I have been diagnosed with Alzheimer's or another brain disease.

I don't have heart or severe health issues that prevent me from exercising.

Health condition contraindicated for increased physical activity

Timeline

Calibration

Participants' average level of physical activity is calibrated by recording daily step counts for 14 days

2 weeks

Daily monitoring via Fitbit

Training

Participants receive the adaptive daily step goal mHealth intervention for 1 month

1 month

Daily monitoring via Fitbit

Follow-up

Participants are monitored for adherence and cognitive health at 1- and 12-months post-intervention

12 months

Assessments at 1- and 12-months post-intervention

Treatment Details

Interventions

• Adaptive Daily Goal Setting
• Interim Goal Prompt

Trial Overview The study tests if an adaptive Fitbit-based app can help increase light physical activity like walking in midlife by setting daily goals. Participants will interact with the app to see if it promotes their cognitive health through increased movement.

Participant Groups

Group I: Treatment Experimental Treatment 2 Interventions

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

Group II: Control Active Control 1 Intervention

Participants receive the adaptive daily step goal mHealth intervention

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Both Goal Management Training and Identity Oriented Goal Training were well-received by participants with traumatic brain injury, leading to improved mood and goal attainment over a 6-8 week period.

Identity Oriented Goal Training effectively engaged participants in the goal-setting process, while Goal Management Training provided a structured approach to prevent errors during goal performance, although both methods were time-intensive for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of self-regulation informed goal setting in people with traumatic brain injury. McPherson, KM., Kayes, N., Weatherall, M.[2014]

The combination of modified Goal Management Training (mGMT) and the RehaGoal App was found to be feasible for helping individuals with executive function impairments after traumatic brain injury (TBI), with all four participants showing improvement in their self-defined goals over an 8-week intervention.

Participants reported excellent usability of the RehaGoal App, and the collected metrics data provided valuable insights into user behavior, suggesting that the app could effectively support rehabilitation efforts and may be suitable for larger studies in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding patients with traumatic brain injury through the instrumental activities of daily living with the RehaGoal App: a feasibility study. Ertas-Spantgar, F., Korabova, S., Gabel, A., et al.[2022]

A study involving 44 older adults (ages 60-83) demonstrated that a strategic memory training program effectively improved both practiced (word list learning) and non-practiced memory tasks (like grocery list learning).

Individuals with higher baseline memory capacity and better cognitive resources, such as processing speed, were more likely to benefit from the training, suggesting that personalized interventions could be designed based on an individual's cognitive profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of strategic memory training in older adults: who benefits most? Rosi, A., Del Signore, F., Canelli, E., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Goal setting and reaction time performance in brain-damaged patients. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of goal setting on the arithmetic performance of brain-damaged patients. [2003]

3. England pubmed.ncbi.nlm.nih.gov

A pilot study of self-regulation informed goal setting in people with traumatic brain injury. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Goal setting approaches and principles used in rehabilitation for people with acquired brain injury: A systematic scoping review. [2018]

5. England pubmed.ncbi.nlm.nih.gov

What are the barriers and facilitators to goal-setting during rehabilitation for stroke and other acquired brain injuries? A systematic review and meta-synthesis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Guiding patients with traumatic brain injury through the instrumental activities of daily living with the RehaGoal App: a feasibility study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Exploring the responsiveness of goal attainment scaling in relation to number of goals set in a sample of hemophilia-A patients. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Goal Attainment Scaling to measure treatment effects in an anti-dementia drug trial. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and validity of ecological momentary cognitive testing among older adults with mild cognitive impairment. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Boston cognitive assessment (BOCA) - a comprehensive self-administered smartphone- and computer-based at-home test for longitudinal tracking of cognitive performance. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Fostering Self-Management of Everyday Memory in Older Adults: A New Intervention Approach. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The effect of strategic memory training in older adults: who benefits most? [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Variability in Cognitive Performance on Mobile Devices Is Sensitive to Mild Cognitive Impairment: Results From the Einstein Aging Study. [2023]