Text Messaging to Increase Activity in Midlife

NCT04849052 | Completed Phase 1 DMC

• 1 other identifier: 2021P000881
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled pilot trial of a text message intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. The MASTERY intervention utilizes two-way text message sessions once-weekly for 12 weeks focusing on performing activities to enhance well being, setting physical activity goals, and learning techniques to reduce midlife-specific stress.

Conditions

Middle Aged

Keywords

Text Message; Physical Activity; Stress Reduction; Positive Psychology; Well-being

Outcome Measures

Primary Outcomes (1)

• Change in Moderate-Vigorous Physical Activity [MVPA]

  ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks. We will report change from baseline to 6 weeks and 12 weeks in the average number of minutes of MVPA performed per day.

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (24)

• Proportion of text message sessions completed

  Weekly over 12 weeks.

• Mean utility ratings of positive psychology text messages

  6 weeks; 12 weeks

• Mean utility ratings of physical activity text messages

  6 weeks; 12 weeks

• Mean utility ratings of stress reduction text messages

  6 weeks; 12 weeks

• Mean utility ratings of phone check-ins

  6 weeks; 12 weeks

Study Arms (2)

MASTERY Intervention

EXPERIMENTAL

Participants will complete a positive psychology activity, work towards a physical activity goal, and use a stress reduction technique, then will complete weekly text message sessions. In the first six weeks, participants will review the activities they performed the prior week, be introduced to new material, choose activities to perform that week, and set a new physical activity goal during the text message sessions. In the final 6 weeks, participants will review progress towards prior goals, set new physical activity goals, and choose positive psychology and stress reduction skills to use that week. Finally, over the course of the program participants will complete three brief calls with a study trainer to discuss progress.

Behavioral: MASTERY

Attentional control

ACTIVE COMPARATOR

Participants will receive the same physical activity component noted in MASTERY along with added messages providing education and guidance about physical activity, from our past work. Control participants will not receive PP or midlife-related content.

Behavioral: Attentional Control

Interventions

MASTERY BEHAVIORAL

In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. Furthermore, study trainers will conduct 4 brief calls with participants (Weeks 1, 4, 7, and 12) to introduce the program, assess progress, answer questions, and provide support.

MASTERY Intervention

Attentional Control BEHAVIORAL

Participants in the control condition will also receive text messages once per week. To ensure time matching, the program will have 4 phone check-ins (on physical activity) as in MASTERY.

Attentional control

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Midlife status (age 45-64 at enrollment).
• Low baseline physical activity (≤150 minutes/week of MVPA\]) as initially self-reported via the well-validated IPAQ and then confirmed via accelerometer after 7 days of wear.

You may not qualify if:

• Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
• An unrelated condition limiting physical activity (e.g., ambulation with a cane or walker, recent or planned surgery, or other condition such that ability to increase moderate to physical activity would be limited).
• Participation in any other programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
• A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen7 designed to assess suitability for research participation.
• Inability to speak/write fluently in English.
• No access to a text message-capable phone.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Psychiatry Research Program

Model Details: Randomized, controlled, single-blinded study

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: September 16, 2021
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)