Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty

Cafe Move: A Novel Program for Prevention of Age-Related Physical Frailty

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.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Behavioral: Cafe Move

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew J Kittelson, PhD; Phone Number: 406-243-4015; Email: andy.kittelson@umontana.edu
• Study Contact Backup: Name: Brian J Loyd; Phone Number: 406-243-4015

Study Locations

• United States
  • Montana
    • Missoula, Montana, United States, 59812
      • Recruiting
      • University of Montana
      • Contact: Andrew J Kittelson; Phone Number: 406-243-4015; Email: andy.kittelson@umontana.edu
      • Contact: Brian J Loyd; Phone Number: 406-243-4015; Email: brian.loyd@umontana.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Behavior Stages of Change Questionnaire	Self-reported measure of engagement with preventive care or wellness activities	through study completion, average of 4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Access and Utilization Questionnaire	Self-reported measure of healthcare utilization of a number of different services	through study completion, average of 4-6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two-minute walk test (2MWT)	Measure of distance walked in 2 minutes along a 50-foot course	through study completion, average of 4-6 months
Grip Strength	Measure of participants' maximum grip strength using a handheld dynamometer	through study completion, average of 4-6 months
Postural Sway	Timed test of participants' ability to balance under 4 different conditions	through study completion, average of 4-6 months
Activities-Specific Balance Confidence Scale	Self-reported questionnaire that assess participants' perceived balance	through study completion, average of 4-6 months
Lifespace Mobility Questionnaire	Self-reported questionnaire that assess participants' interaction with home and community settings	through study completion, average of 4-6 months
Role Participation Questionnaire	Self-reported questionnaire that captures various social, demographic, and activity level information from participants	through study completion, average of 4-6 months
Physical Function Questionnaire	Self-reported questionnaire assessing perceived function with daily activities	through study completion, average of 4-6 months

Collaborators and Investigators

• Sponsor: University of Montana

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Balance; Mobility; Frailty; Strength; Physical function
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: 76-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No