NCT07194239

Brief Summary

The goal of this clinical trial is to determine the clinical effectiveness of lifestyle medicine in reducing chronic musculoskeletal pain in older adults, as measured by pain intensity, pain interference, self-management efficacy, stress level, sleep quality, healthier diet, better quality of life, and cost-effectiveness, compared to a waitlist control group. Participants will be randomly assigned to either the intervention or the waitlist group. The intervention group will meet the health coach face-to-face for four sessions to negotiate and set personalized health goals. The waitlist control group will continue to receive usual care without any additional intervention for 24 weeks. Both groups will complete three assessments: at the start of the study, one month after the intervention, and three months after the intervention. The waitlist control group will be offered the same intervention after completing the study.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Nov 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Nov 2025Oct 2027

First Submitted

Initial submission to the registry

September 17, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 17, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

Musculoskeletal painlifestyle medicineolder peoplehealth coachingChronic Musculoskeletal PainBehavior change

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory - Severity score

    The Brief Pain Inventory (BPI) is a self-report questionnaire that assesses the intensity of pain and its effects on daily functioning. BPI- Severity measures the intensity of pain. Participants are asked to rate their pain on a 0-10 Numeric Rating Scale for their pain experienced at its "worst," "least," "average," and "now" over the past 24 hours. Higher scores indicate greater pain severity.

    Week 0, 12, 24

Secondary Outcomes (10)

  • BPI-Interference

    week 0, 12, 24

  • Pain-Self Efficacy questionnaire

    Week 0 12, 24

  • Chinese International Physical Activity Questionnaire (Short form)

    Week 0, 12, 24

  • Chinese Short Food Frequency Questionnaire

    Week 0, 12, 24

  • 10-item Perceived Stress Scale (PSS-10)

    Week 0, 12, 24

  • +5 more secondary outcomes

Study Arms (2)

Waitlist control

NO INTERVENTION

Patients allocated to the Waitlist arm will continue receiving their "usual care" without any additional intervention until they have completed the outcome assessment at 24 weeks.

Intervention group

EXPERIMENTAL

A coaching context to enhance the well-being of individuals and to facilitate the achievement of their health-related goals. The coach will negotiate and set personalized health goals with participants, ensuring the goals are realistic, achievable, and aligned with their needs.

Behavioral: Lifestyle medicine Health coaching

Interventions

Participants assigned to this group will have 4 face-to-face sessions with the health coach. Lifestyle modifications with the aim of pain reduction will be determined in a shared decision-making approach. Lifestyle modifications will be based on the 6 pillars of lifestyle medicine: Physical activity, Healthy eating, Stress reduction, Sleep restoration, Social Support, and Avoiding risky substances. The health coach will make use of motivational techniques such as motivational interviewing to guide and assist participants in realizing the lifestyle modifications.

Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic musculoskeletal pain, defined as pain that lasted for more than 3 months persistently or intermittently, including regional pain (joints, limbs, back, and/or neck)
  • a degenerative joint condition, such as osteoarthritis, and/or musculoskeletal complaints that fall under the classification of the International Classification of Disease-11 as "chronic primary musculoskeletal pain" or "chronic secondary musculoskeletal pain"
  • Pain intensity score ≥ 4 on a numerical rating scale of 10
  • stable baseline physical activity
  • ability to understand written and verbal Chinese

You may not qualify if:

  • patient with cancer-related pain
  • inflammatory rheumatic disease
  • a recent history of stroke or major surgery in the past 6 months
  • terminal illness
  • serious mental illness
  • severe or uncontrolled heart disease
  • comorbid conditions that might impede active participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaChronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPainMuscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Clinical)

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 26, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

September 26, 2025

Record last verified: 2025-09