A Tailored Program to Promote Well-being and Physical Activity in Mid-life Adults With Low Physical Activity

NCT04745182 | Completed

• 1 other identifier: 2019P002328
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the 12-week, phone-delivered, Midlife Activity, Stress reduction, Time Efficiency, Resilience, and Youthfulness (MASTERY) intervention, which utilizes positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote well-being and physical activity in mid-life adults.

Conditions

Middle Aged; Exercise

Outcome Measures

Primary Outcomes (3)

• Proportion of total phone sessions completed

  To assess the feasibility of the intervention

  12 weeks

• Mean ease ratings of exercises

  To assess how easy participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being very difficult and 10 being very easy.

  12 weeks

• Mean utility ratings of exercises

  To assess how useful participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being not at all useful and 10 being very useful.

  12 weeks

Secondary Outcomes (6)

• Proportion of sessions completed by participants

  12 weeks

• Change in Moderate-Vigorous Physical Activity

  Change from Baseline to 12 weeks

• Change in Positive Affect

  Change in score from Baseline to 12 weeks

• Change in Optimism

  Change in score from Baseline to 12 weeks

• Change in Depression

  Change in score from Baseline to 12 weeks

Study Arms (1)

MASTERY

EXPERIMENTAL

For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and will contain space to write a specific physical activity goal and to track physical activity (e.g., through step counter data) over the subsequent week. At the in-person visit #2, interventionists will explain PP exercise 1 and MI session 1 to the participants. Calls will last \~30 minutes. Participants will then independently complete PP exercises and MI-based goals and review them at phone sessions over 12 weeks. PP and MI components will be delivered stepwise within sessions (rather than intertwined) based on our experience, participant feedback, and pilot work.

Behavioral: MASTERY

Interventions

MASTERY BEHAVIORAL

A 12-week, phone-delivered intervention utilizing positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote physical activity and well-being in mid-life adults.

MASTERY

Eligibility Criteria

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

You may qualify if:

• Age 45-64 years at time of enrollment.
• Low physical activity (defined as ≤150 minutes/week of MVPA, in accordance with consensus recommendations for moderate or greater intensity aerobic physical activity and measured using a brief version of the well-validated International Physical Activity Questionnaire (IPAQ) scale.

You may not qualify if:

• Existing coronary artery disease. Coronary artery disease will be identified through review of the medical record, with clarification by participants' primary clinician if needed, as part of recruitment procedures. Existing coronary artery disease will be defined as a prior acute coronary syndrome (unstable angina or myocardial infarction) or diagnosed via cardiac catheterization.
• To meet criteria for a prior acute coronary syndrome, for myocardial infarction, patients must have experienced at least two of three World Health Organization criteria for an acute myocardial infarction: typical chest pain, elevated cardiac enzymes, and electrocardiographic changes consistent with myocardial infarction.
• For unstable angina, participants must have had new onset angina within 2 months, exacerbation of previous angina with rest pain or with minimal exercise, or angina within 2 weeks of myocardial infarction, with confirmation of this diagnosis by the patient's primary medical provider or inpatient treatment team; this definition has been used in prior trials.
• To meet criteria for coronary artery disease diagnosed at cardiac catheterization, participants must have had 50% stenosis of the left main artery or 70% stenosis of another coronary artery, consistent with consensus definitions of obstructive coronary artery disease.
• Cognitive disturbance precluding participation or informed consent, as identified using a six-item cognitive screen designed to assess suitability for research participation.
• Lack of available telephone.
• An inability to communicate in English.
• A condition limiting physical activity (e.g., arthritis, chronic obstructive pulmonary disease), identified by patient and medical record, confirmed by primary medical provider as needed.
• Participation in similar programs (e.g., mind-body interventions) as reported by patients.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Huffman JC, Massey CN, Chung WJ, Harnedy LE, Carrillo A, Feig EH, Celano CM. A Psychological-Behavioral Intervention to Improve Physical Activity in Midlife Adults With Low Baseline Physical Activity. Prim Care Companion CNS Disord. 2021 Jul 29;23(4):20m02876. doi: 10.4088/PCC.20m02876.

  PMID: 34324798 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hopsital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Psychiatry Research Program

Model Details: All participants were in the same group and received the same intervention.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 9, 2021
• Study Start: October 1, 2019
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)