Text Messaging to Increase Activity in Midlife

NCT ID: NCT04849052

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2024-09-16

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.

Detailed Description

This is a randomized controlled pilot trial of a multipronged intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. 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. The messages will focus on 3 distinct areas in the same order each week: (1) well-being-based skills and assigned activities, customized for midlife adults, (2) physical activity content focused on setting and reaching weekly activity goals, and (3) specific skills to manage midlife-related stressors that act as barriers to activity. The primary outcome is objectively measured moderate to vigorous physical activity (MVPA). Secondary outcomes include feasibility and acceptability and other activity-related, psychological, and functional outcomes at 12 weeks.

Conditions

Middle Aged

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

MASTERY Intervention

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.

Group Type: EXPERIMENTAL

MASTERY

Intervention Type: 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.

Attentional control

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.

Group Type: ACTIVE_COMPARATOR

Attentional Control

Intervention Type: 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.

Interventions

MASTERY

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.

Intervention Type: BEHAVIORAL

Attentional Control

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Midlife status (age 45-64 at enrollment).

2. 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.

Exclusion Criteria

1. Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).

2. 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).

3. Participation in any other programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).

4. A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen7 designed to assess suitability for research participation.

5. Inability to speak/write fluently in English.

6. No access to a text message-capable phone.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeff C. Huffman, MD

Director, Cardiac Psychiatry Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff C Huffman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P000881

Identifier Type: -

Identifier Source: org_study_id