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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Fitbit-based app that sets daily activity goals (Adaptive Daily Goal Setting) can help middle-aged adults increase their light physical activity. Participants will use either the app alone or with additional goal-setting prompts (Interim Goal Prompt) to determine the most effective method. The trial is suitable for adults with a BMI of 25 or higher who do not have serious health conditions that prevent increased activity. As an unphased trial, it offers participants the chance to contribute to innovative research on enhancing physical activity through technology.

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 prior data suggests that this adaptive goal setting application is safe for cognitive health?

Research has shown that goal-setting apps, like the one in this study, are safe to use. Studies have found that using these apps to set flexible goals can help people become more active without serious side effects. By making tasks feel like a game, these apps are both fun and effective for users.

The daily goal setting tested in this trial mirrors methods used in past studies. Those studies found that setting clear, achievable goals helps people stay active. No major health risks were reported, suggesting that this approach is safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the adaptive daily goal setting method for cognitive health because it offers a personalized approach to improving mental agility. Unlike standard cognitive training programs, which can be rigid and generic, this technique adapts to each individual's progress by setting daily step goals and providing prompts to encourage consistent engagement. This dynamic and interactive approach could lead to more effective and sustained improvements in cognitive function, making it a promising tool in cognitive health management.

What evidence suggests that this trial's treatments could be effective for increasing light intensity physical activity?

Research has shown that setting flexible goals can greatly increase physical activity. One study demonstrated that using a Fitbit app led to an 86.7% rise in daily steps, increasing from about 5,436 to over 10,150 steps a day. Another study found that personalized step goals sent through an app significantly boosted daily step counts. In this trial, participants in the treatment arm will receive an adaptive daily step goal mHealth intervention along with interim goal-setting prompts each day. These findings suggest that setting daily activity goals with mobile health (mHealth) apps can effectively encourage more movement, potentially benefiting brain health and overall well-being. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan G Hakun, PhD

Principal Investigator

Milton S. Hershey Medical Center

Are You a Good Fit for This Trial?

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

BMI ≥ 25

I am between 30 and 70 years old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05826379

Daily Goal Setting to Increase Everyday Physical Activity ... The study is designed to examine the efficacy of a Fitbit-based, goal setting, mHealth intervention to increase light intensity physical activity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11970563/

Personalized mHealth Intervention (StepAdd) for Increasing ... The pilot saw an 86.7% increase in mean daily step counts, from 5436 (SD 2231) per day to 10,150 (SD 3908) per day, and a reduction of mean HbA ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8265041/

Effectiveness of the mHealth intervention 'MyDayPlan' to ... Results showed an average intervention effect with a significant increase in number of daily steps from the control to intervention phases for each AB ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1532046423002022

StepAdd: A personalized mHealth intervention based on ... Daily step count increased dramatically with high statistical significance (p < 0.0001), from a mean of 5436 steps/day to 10,150 steps/day, an 86.7 % increase.

5. mhealth.jmir.org mhealth.jmir.org/2018/1/e28/

Evaluating Machine Learning–Based Automated ... Through the app, the intervention group received fully automated adaptively personalized daily step goals, and the control group received ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9015741/

Evaluating the Impact of Adaptive Personalized Goal ... Promising results have been obtained by using gamification techniques as behavior change strategies, especially when they were tailored toward an individual's ...

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-017-4197-8

Adaptive goal setting and financial incentives: a 2 × 2 factorial ... A 4-month 2 × 2 factorial randomized controlled trial tested main effects for goal setting (adaptive vs. static goals) and rewards (immediate vs ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667032125000435

Practical approaches to lifestyle interventions for ... Remember that goals should be specific, measurable, achievable, relevant, and time-bound (SMART), providing a clear direction for the patient [53]. (2). Deliver ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35000693/

Adaptive Goals and Reinforcement Timing to Increase ... This trial tested the independent and joint effects of a mobile health system automating adaptive goal setting and immediate financial reinforcement for ...