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

NCT ID: NCT06403345

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2026-08-30

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single arm pre/post study

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.

Group Type: EXPERIMENTAL

Green Activity Program

Intervention Type: BEHAVIORAL

See arm description.

Interventions

Green Activity Program

See arm description.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• 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

• 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.
• 2 or more hospitalizations in 6 months

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Federation for Aging Research

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Lassell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Lassell, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana Unversity

Locations

Indiana University Bloomington

Bloomington, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Lassell, PhD

Role: CONTACT

blassell@iu.edu

812-855-2395

Triana Pena

Role: CONTACT

tripena@iu.edu

Facility Contacts

Rebecca Lassell, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 41092385 (View on PubMed)

Other Identifiers

22206

Identifier Type: -

Identifier Source: org_study_id