Mild Cognitive ImpairmentGAPNCT06403345
A Feasiblity Study of Green Activity Program for People Living With Memory Challenges
A study testing Green Activity Program in people with Mild Cognitive Impairment and Alzheimer Disease, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Subjective Cognitive Decline (SCD)
- What is being tested?
- Green Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years or older
- Has memory challenges or difficulties thinking
- Have access and ability to respond to the telephone (mobile or landline)
- Study partner
- 18 years or older
- Speaks Spanish or English
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- Identified by the PLMC as a person they feel comfortable with who they would like to join them in the study. The study partner's participation is based on level of support needed for the PLMC.
- Outdoor activity professionals
- 18 years or older
- at least 1 year experience providing outdoor activities
Who cannot join
- Participants living with memory challenges will be excluded if they do not meet inclusion criteria or if they indicate any of the following on the 2023 Physical Activity Readiness Questionnaire + (PAR-Q+) :
- Heart failure or, difficulty controlling Coronary Artery Disease, Diagnosed Abnormality of Heart Rhythm, or other cardiovascular condition.
- If they report difficulty controlling CAD, Diagnosed abnormality of heart rhythm they will be excluded.
- If they endorse a diagnosis of heart failure, AND report symptoms greater than NYHA Functional Classification Stage I: "No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath," they will be excluded. Research assistants will be trained to ask about these symptoms during usual activities of daily living.
- If their doctor has told them not to participate in physical activity due to their heart condition or another medical condition, they will be excluded.
- Cancer and are in an active cycle of infusion chemotherapy or daily radiation treatments.
Show all 11Show fewer
- People with cancer whose treatment regimen does not impact their day to day routines (e.g.-oral chemotherapy agents) may participate. Research assistants will be trained to ask about the impact of cancer and cancer care on day to day activities and physical activity.
- If their doctor has told them not to participate in physical activity due to their cancer or cancer treatment or another medical condition, they will be excluded.
- Experienced a black out, fainted, or lost consciousness as a result of a head injury in the past 12 months.
- Often experienced signs and symptoms of low blood sugar (hypoglycemia) following exercise and/or daily activities.
- 2 or more hospitalizations in 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Triana Pena contact
United States1 site, 1 recruiting
- Recruiting
Indiana University Bloomington
Bloomington, Indiana, 47401
Rebecca Lassell, PhD
About this study
The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.
Read the detailed description
This is a single arm pre/post feasibility study lasting up to 1 year. Investigators will recruit in n=40 dyads (people living with memory challenges and their study partners n=80 total) and expect n=30 (n=60 total people living with memory challenges and study partners) to complete the 12-week GAP and evaluate it for feasibility and acceptability. Anonymous program evaluation surveys will be administered either via paper or RedCap survey to the outdoor activity professionals who participated in the study. Brief recorded phone interviews (5 minutes) will be conducted with the people living with memory challenges and their study partners after the intervention and 15-minute brief calls with the outdoor activity professionals will be used to gather feedback to refine the program. Informal conversations with the occupational therapist(s) delivering the intervention will occur to identify areas for refinement and will be documented with anonymous notes and no identifiable data collected from them. Sustained behavior change will be measured in people living with memory challenges at 4 weeks after the intervention.
- Being tested
- Green Activity Program
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Activity ProgramBehavioural
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Single arm pre/post study | Experimental | GAP 12-week Intervention for People Living with Memory Loss \& Study Partners involves an evaluation, goal-setting, coaching and strategy training over 4-8 virtual or phone sessions for 30-90 minutes each over 12 weeks, with 2 phone or virtual check-ins for 15-30 minutes.
GAP Intervention Outdoor Activity Professionals involves a site-evaluation (Accessibility, Fall risk) and education on Dementia Training, SMART Goal setting, Strategy Training for Tailoring Nature Activities, and Behavioral Activation strategies with support from the OT. Receives: Behavioral: Green Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility intervention completion rate
intervention completion rate of 75%
Measured: Through study completion
Other Feasibility measures
75% attendance, 75% retention, intervention fidelity using a checklist by an outside rater with at least 75% of potential active ingredients present in 25% of randomly sampled sessions: tailoring (environment, activity, personalized delivery), behavioral activation, and nature (outdoor environment or incorporating nature [plant or animal]). Feasibility data of recruitment rates (eligible participants/# recruited per month), feasibility of assessments (time to complete, with an 80% completion rate) will be collected, and we will also track missing data.
Measured: Through study completion
Acceptability
Two selected questions from the Intervention Tolerability scale will be asked to the person living with memory challenges over the phone: "The program was easy to use" and "I liked this program." Rated by (yes/no). We expect at least 70% of people living with memory challenges will be satisfied with the intervention (yes to both questions).
Measured: Up to one month after the 12-week program.
Secondary outcomes (28)
Goal Attainment Scaling
Primary goal met (yes/no)
Measured: Up to one month after the 12-week program
Quick Physical Activity Scale
Physical activity
Measured: Up to 1 month before and after the 12-week program
Heart Rate
ActiGraph LEAP
Measured: 1 week pre 12-week program and 1 week post
Physical activity
ActiGraph LEAP
Measured: 1 week pre 12-week program and 1 week post
Sedentary time
ActiGraph LEAP
Measured: 1 week pre 12-week program and 1 week post
Health
Patient-Reported Outcomes Measurement Information System: Physical health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Measured: Up to 1 month before and after the 12-week program
Well-being
Patient-Reported Outcomes Measurement Information System: Mental Health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Measured: Up to 1 month before and after the 12-week program
Social Participation
Patient-Reported Outcomes Measurement Information System: Satisfaction with participation in social activities. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Measured: Up to 1 month before and after the 12-week program
Depression
Geriatric Depression Scale short form,
Measured: Up to 1 month before and after the 12-week program
Behavioral Activation
Behavioral Activation Scale Short Form
Measured: Up to 1 month before and after the 12-week program
Sleep
ActiGraph LEAP
Measured: 1 week before and 1 week after the 12 week intervention
UCLA 3-item Loneliness scale
Loneliness
Measured: Up to 1 month before and after the 12-week program
Neuropsychiatric symptoms
Neuropsychiatric symptoms questionnaire
Measured: Up to 1 month before and after the 12-week program
Brief phone interviews
2 -Post questions over the phone: "What did you like about the program? What would you change?"
Measured: Up to 1 month after the 12-week program
Study Partner Health
Patient-Reported Outcomes Measurement Information System: Physical health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Measured: Up to 1 month before and after the 12-week program
Study Partner well-being
Patient-Reported Outcomes Measurement Information System: Mental Health. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Measured: Up to 1 month before and after the 12-week program
Study Partner Social Participation
Patient-Reported Outcomes Measurement Information System: Satisfaction with participation in social activities. Scored on the T-score metric. High scores mean more of the concept being measured.
A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Measured: Up to 1 month before and after the 12-week program
Study Partner Depression
Geriatric Depression Scale short form
Measured: Up to 1 month before and after the 12-week program
Feasibility for Study partner
Feasibility of an Intervention Measure
Measured: Up to 1 month after the 12-week program
Acceptability for Study Partner
Acceptability of an Intervention Measure
Measured: Up to 1 month after the program
Appropriateness for Study Partner
Appropriateness of an Intervention Measure
Measured: Up to 1 month after the 12-week program
Brief phone interview
"What did you like about the program? What would you change?"
Measured: Up to 1 month after the 12-week program
Outdoor Professional Dementia Knowledge
Dementia Knowledge Assessment
Measured: Up to 1 month before and after the dementia training
Outdoor Professional strategies for tailoring activities
Strategies for Tailoring Activities quiz
Measured: Up to 1 month before and after the strategy training
Outdoor Professional brief phone interview
15-minute brief phone interview post
Measured: Up to 2 weeks after the 12 week program
Sustained Behavior Change for People Living with Memory Challenges
3 Questions asked via phone
- Are you still doing the activities?
- (If yes) Do you plan to continue doing the activities? (If no) Why not? Do plan to do them in the future?
- Have you added any new activities?
Measured: 1 month after the 12 week program
Cognitive function
T-MoCa
Measured: Up to 1 month before and after 12 week program
Usability
Holden's Simplified Systems Usability Scale (SSUS)
Measured: up to 2 weeks after baseline testing with the ActiGraph LEAP and CenterePointe App software
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start17 Jul 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Federation for Aging Research
- Responsible party
- Principal investigator, Rebecca Lassell, Indiana University
- Investigators
- Rebecca Lassell, PhD, Principal investigator, Indiana Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403345
- Sponsor's protocol ID
- 22206
- Acronym
- GAP
- Status last verified
- Jul 2026
- First submitted
- 26 Apr 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lassell R, Metaxas A, Wang K, Hantgan S, Gottipati P, Zwerling S, Pena T, Pollak C, Gitlin L, Jariwala S. Applying the Human-Centered Innovation Biodesign Framework to the Development and Piloting of a Program to Mitigate Risk for Cognitive Decline Among Historically Underrepresented Individuals: Case Study. JMIR Form Res. 2025 Oct 15;9:e64930. doi: 10.2196/64930.
PubMed 41092385
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasiblity Study of Green Activity Program for People Living With Memory Challenges
- ClinicalTrials.gov ID
- NCT06403345
- Acronym / sponsor ID
- GAP / 22206
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Federation for Aging Research
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.
Detailed description
This is a single arm pre/post feasibility study lasting up to 1 year. Investigators will recruit in n=40 dyads (people living with memory challenges and their study partners n=80 total) and expect n=30 (n=60 total people living with memory challenges and study partners) to complete the 12-week GAP and evaluate it for feasibility and acceptability. Anonymous program evaluation surveys will be administered either via paper or RedCap survey to the outdoor activity professionals who participated in the study. Brief recorded phone interviews (5 minutes) will be conducted with the people living with memory challenges and their study partners after the intervention and 15-minute brief calls with the outdoor activity professionals will be used to gather feedback to refine the program. Informal conversations with the occupational therapist(s) delivering the intervention will occur to identify areas for refinement and will be documented with anonymous notes and no identifiable data collected from them. Sustained behavior change will be measured in people living with memory challenges at 4 weeks after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm pre/post study | Experimental | Behavioral: Green Activity ProgramGAP 12-week Intervention for People Living with Memory Loss \& Study Partners involves an evaluation, goal-setting, coaching and strategy training over 4-8 virtual or phone sessions for 30-90 minutes each over 12 weeks, with 2 phone or virtual check-ins for 15-30 minutes. GAP Intervention Outdoor Activity Professionals involves a site-evaluation (Accessibility, Fall risk) and education on Dementia Training, SMART Goal setting, Strategy Training for Tailoring Nature Activities, and Behavioral Activation strategies with support from the OT. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 45 years or older
- Has memory challenges or difficulties thinking
- Have access and ability to respond to the telephone (mobile or landline)
- Study partner
- 18 years or older
Key exclusion criteria (11 listed)
- Participants living with memory challenges will be excluded if they do not meet inclusion criteria or if they indicate any of the following on the 2023 Physical Activity Readiness Questionnaire + (PAR-Q+) :
- Heart failure or, difficulty controlling Coronary Artery Disease, Diagnosed Abnormality of Heart Rhythm, or other cardiovascular condition.
- Cancer and are in an active cycle of infusion chemotherapy or daily radiation treatments.
- Experienced a black out, fainted, or lost consciousness as a result of a head injury in the past 12 months.
- Often experienced signs and symptoms of low blood sugar (hypoglycemia) following exercise and/or daily activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Activity ProgramSee arm description. | Behavioural | Single arm pre/post study |
Primary outcome
Feasibility intervention completion rate
Time frame: Through study completion
intervention completion rate of 75%
Other Feasibility measures
Time frame: Through study completion
75% attendance, 75% retention, intervention fidelity using a checklist by an outside rater with at least 75% of potential active ingredients present in 25% of randomly sampled sessions: tailoring (environment, activity, personalized delivery), behavioral activation, and nature (outdoor environment or incorporating nature [plant or animal]). Feasibility data of recruitment rates (eligible participants/# recruited per month), feasibility of assessments (time to complete, with an 80% completion rate) will be collected, and we will also track missing data.
Acceptability
Time frame: Up to one month after the 12-week program.
Two selected questions from the Intervention Tolerability scale will be asked to the person living with memory challenges over the phone: "The program was easy to use" and "I liked this program." Rated by (yes/no). We expect at least 70% of people living with memory challenges will be satisfied with the intervention (yes to both questions).
28 secondary outcomes
Goal Attainment Scaling
Time frame: Up to one month after the 12-week program
Quick Physical Activity Scale
Time frame: Up to 1 month before and after the 12-week program
Heart Rate
Time frame: 1 week pre 12-week program and 1 week post
Physical activity
Time frame: 1 week pre 12-week program and 1 week post
Sedentary time
Time frame: 1 week pre 12-week program and 1 week post
Health
Time frame: Up to 1 month before and after the 12-week program
Well-being
Time frame: Up to 1 month before and after the 12-week program
Social Participation
Time frame: Up to 1 month before and after the 12-week program
Depression
Time frame: Up to 1 month before and after the 12-week program
Behavioral Activation
Time frame: Up to 1 month before and after the 12-week program
Sleep
Time frame: 1 week before and 1 week after the 12 week intervention
UCLA 3-item Loneliness scale
Time frame: Up to 1 month before and after the 12-week program
Neuropsychiatric symptoms
Time frame: Up to 1 month before and after the 12-week program
Brief phone interviews
Time frame: Up to 1 month after the 12-week program
Study Partner Health
Time frame: Up to 1 month before and after the 12-week program
Study Partner well-being
Time frame: Up to 1 month before and after the 12-week program
Study Partner Social Participation
Time frame: Up to 1 month before and after the 12-week program
Study Partner Depression
Time frame: Up to 1 month before and after the 12-week program
Feasibility for Study partner
Time frame: Up to 1 month after the 12-week program
Acceptability for Study Partner
Time frame: Up to 1 month after the program
Appropriateness for Study Partner
Time frame: Up to 1 month after the 12-week program
Brief phone interview
Time frame: Up to 1 month after the 12-week program
Outdoor Professional Dementia Knowledge
Time frame: Up to 1 month before and after the dementia training
Outdoor Professional strategies for tailoring activities
Time frame: Up to 1 month before and after the strategy training
Outdoor Professional brief phone interview
Time frame: Up to 2 weeks after the 12 week program
Sustained Behavior Change for People Living with Memory Challenges
Time frame: 1 month after the 12 week program
Cognitive function
Time frame: Up to 1 month before and after 12 week program
Usability
Time frame: up to 2 weeks after baseline testing with the ActiGraph LEAP and CenterePointe App software
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 41092385Lassell R, Metaxas A, Wang K, Hantgan S, Gottipati P, Zwerling S, Pena T, Pollak C, Gitlin L, Jariwala S. Applying the Human-Centered Innovation Biodesign Framework to the Development and Piloting of a Program to Mitigate Risk for Cognitive Decline Among Historically Underrepresented Individuals: Case Study. JMIR Form Res. 2025 Oct 15;9:e64930. doi: 10.2196/64930.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Triana Pena contact
Rebecca Lassell, PhD principal investigator
Indiana Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Activity Program in people with Mild Cognitive Impairment and Alzheimer Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Lassell, PhD (812-855-2395, blassell@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility intervention completion rate (time frame: Through study completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.