NCT06172933

Brief Summary

This is a randomized, controlled pilot trial (N=30) to examine the feasibility, acceptability, and preliminary efficacy of the Move with Meaning program, an 8- week, text message- and audio-based intervention to promote physical activity in midlife adults.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2024Aug 2026

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

December 7, 2023

Last Update Submit

April 9, 2026

Conditions

Keywords

Text messagePodcastWell-beingPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Proportion of text message sessions successfully delivered

    The automated platform will record rates of successful text message delivery.

    Weekly over 8 weeks

Secondary Outcomes (14)

  • Proportion of audio sessions completed by participants

    Weekly over 8 weeks

  • Session utility

    Weekly over 8 weeks

  • Change in overall physical activity (in steps/day)

    Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)

  • Change in moderate to vigorous physical activity (MVPA; in mean minutes/day)

    Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)

  • Change in sedentary time (in mean minutes/day)

    Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)

  • +9 more secondary outcomes

Study Arms (2)

Move with Meaning

EXPERIMENTAL

In Move with Meaning, participants will engage in twice weekly, interactive text message sessions, which are accompanied by audio content to promote engagement in the program. In the first session of each week, participants will review their physical activity goal and positive psychology topic from last week, then learn about a new positive psychology and physical activity topic and ultimately set a new physical activity goal for the week. In the second session, participants will either be reminded of the content of the audio file and the goal they set earlier that week. The program will run for eight weeks.

Behavioral: Move with Meaning

Wait-list control

NO INTERVENTION

Participants in the wait-list control condition will engage in usual medical care for eight weeks, then will complete the Move with Meaning program.

Interventions

Participants will engage in twice weekly text message sessions, will listen to a weekly audio session, and will work towards a physical activity goal each week, for a total of eight weeks.

Move with Meaning

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Midlife adults (aged 45-64 years at the time of enrollment)
  • Suboptimal physical activity (\<150 minutes of moderate to vigorous physical activity, measured by accelerometer)
  • Access to a phone capable of receiving text messages and listening to audio files (i.e., a smartphone)

You may not qualify if:

  • An unrelated condition limiting physical activity
  • Participation in any other programs focused on cardiac prevention or well-being
  • A cognitive disturbance precluding participation or informed consent
  • Current pregnancy
  • Inability to speak/write fluently in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christopher M Celano, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
While participants and study trainers will be aware of group assignment, a blinded study team member will perform outcome assessments.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, wait-list controlled, blinded intervention trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Cardiac Psychiatry Research Program

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

September 23, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations