A Feasiblity Study of Green Activity Program for People Living With Memory Challenges

NCT06403345 | Recruiting

• 1 other identifier: 22206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Subjective Cognitive Decline (SCD)

Outcome Measures

Primary Outcomes (3)

• Feasibility intervention completion rate

  intervention completion rate of 75%

  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.

  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).

  Up to one month after the 12-week program.

Secondary Outcomes (28)

• Goal Attainment Scaling

  Up to one month after the 12-week program

• Quick Physical Activity Scale

  Up to 1 month before and after the 12-week program

• Heart Rate

  1 week pre 12-week program and 1 week post

• Physical activity

  1 week pre 12-week program and 1 week post

• Sedentary time

  1 week pre 12-week program and 1 week post

Study Arms (1)

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.

Behavioral: Green Activity Program

Interventions

Green Activity Program BEHAVIORAL

See arm description.

Single arm pre/post study

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Has memory challenges or difficulties thinking
• Have access and ability to respond to the telephone (mobile or landline)
• Study partner
• years or older
• Speaks Spanish or English
• 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
• years or older
• at least 1 year experience providing outdoor activities

You may not qualify if:

• 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.
• 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.
• or more hospitalizations in 6 months

Sponsors & Collaborators

• Indiana University: lead
• American Federation for Aging Research: collaborator

Study Sites (1)

Indiana University Bloomington

Bloomington, Indiana, 47401, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41092385 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Rebecca Lassell, PhD

  Indiana Unversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Lassell, PhD

CONTACT

812-855-2395; blassell@iu.edu

Triana Pena

CONTACT

tripena@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 7, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)