Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty

NCT ID: NCT05720507

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-29
• Study Completion Date: 2026-02-28

Brief Summary

This project explores a novel means of health promotion and prevention of age-related physical frailty, which is designed to overcome barriers to access and promote autonomy in managing physical health.

Detailed Description

The purpose of this investigation is to field-test a physical function assessment paradigm, designed to inform people of their physical function relative to peers of similar demographic characteristics (e.g., similar age, sex, height, etc.), to promote recommended preventive health behaviors. The physical function assessment paradigm is known as Cafe Move. Our primary research hypothesis is that people will advance along the stages of behavior change (i.e., more likely to participate in recommended preventive healthcare for physical function), after accessing Cafe Move assessments. This study is a single cohort (n=36 participants), double-baseline design, intended primarily to collect pilot data. The results will inform the design of a larger controlled trial.

This study will examine the safety, feasibility, acceptability, and preliminary efficacy of Café Move. Briefly, we will make Café Move available to at-risk populations (i.e., independent-living older adults) via the following approach. First, during a 3-month control phase, we will monitor participants' health behaviors and engagement with preventive health offerings via periodic phone surveys. We will then make Café Move available and subsequently monitor health behaviors and engagement with preventive health offerings. This design will allow us to examine feasibility of the Café Move intervention, to better understand the reach of the program within and across communities, and to determine variance and covariance for the outcome measures of interest.

Conditions

Aging

Study Design

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

Interventions

Cafe Move

Participants will be offered the opportunity to choose from a number of physical function assessments and subsequently provided personalized reports of performance results.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Legally autonomous to consent
• Lives independently
• Ability to sit, stand, and walk without the assistance of another person

Exclusion Criteria

• Not legally autonomous to consent
• Institutionalized

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Montana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Montana

Missoula, Montana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrew J Kittelson, PhD

Role: CONTACT

andy.kittelson@umontana.edu

406-243-4015

Brian J Loyd

Role: CONTACT

406-243-4015

Facility Contacts

Andrew J Kittelson

Role: primary

andy.kittelson@umontana.edu

406-243-4015

Brian J Loyd

Role: backup

brian.loyd@umontana.edu

406-243-4015

Other Identifiers

76-22

Identifier Type: -

Identifier Source: org_study_id