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

Exercise Clinical Trial

— MASTERY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745182
• Other study ID #: 2019P002328
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 19, 2020

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-arm proof-of-concept trial of a phone-delivered positive psychology-motivational interviewing (PP-MI) intervention, with content adapted to midlife persons. Midlife adults with low physical activity were recruited from outpatient clinics, completed baseline outcome measures (including wearing an accelerometer to measure activity for one week), completed the 12-week MASTERY intervention, and then completed a follow-up session to obtain repeat outcome information. The intervention, which involved weekly phone sessions with a trained study team member, included the completion of PP exercises, setting physical activity goals, and completion of activities to reduce midlife-specific stressors. The primary outcomes were feasibility and acceptability, and secondary outcomes included accelerometer-measured physical activity and self-report outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Exercise
• Middle Aged

Intervention

Behavioral:
• MASTERY
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of total phone sessions completed	To assess the feasibility of the intervention	12 weeks
Primary	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
Primary	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	Proportion of sessions completed by participants	To assess the feasibility of study procedures. We will divide the number of phone sessions completed by participants by the total number of phone sessions that could have been completed.	12 weeks
Secondary	Change in Moderate-Vigorous Physical Activity	ActiGraph GT3X+ step counters 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 and at 12 weeks. We will report change from baseline to 12 weeks in the average number of minutes of MVPA performed per day.	Change from Baseline to 12 weeks
Secondary	Change in Positive Affect	The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of positive affect.	Change in score from Baseline to 12 weeks
Secondary	Change in Optimism	Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of optimism.	Change in score from Baseline to 12 weeks
Secondary	Change in Depression	The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of depression.	Change in score from Baseline to 12 weeks
Secondary	Change in Anxiety	The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of anxiety.	Change in score from Baseline to 12 weeks