Text Messaging to Increase Activity in Midlife

Middle Aged Clinical Trial

— MASTERY  

Official title:

A Randomized Pilot Trial of a Multicomponent Interactive Text Message Intervention to Promote Physical Activity in Midlife Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04849052
• Other study ID #: 2021P000881
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 16, 2021
• Est. completion date: August 19, 2024

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Middle Aged

Intervention

Behavioral:
• 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.
• 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.

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	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	Proportion of text message sessions completed	To assess the feasibility of the MASTERY intervention the automated platform will record rates of the proportion of text message sessions in which participants respond and set a physical activity goal.	Weekly over 12 weeks.
Secondary	Mean utility ratings of positive psychology text messages	Participants will rate the utility of the positive psychology text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).	6 weeks; 12 weeks
Secondary	Mean utility ratings of physical activity text messages	Participants will rate the utility of the physical activity text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).	6 weeks; 12 weeks
Secondary	Mean utility ratings of stress reduction text messages	Participants will rate the utility of the stress reduction text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).	6 weeks; 12 weeks
Secondary	Mean utility ratings of phone check-ins	Participants will rate the utility of the phone sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).	6 weeks; 12 weeks
Secondary	Change in overall physical activity	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 steps per day.	Baseline, 6 weeks, 12 weeks
Secondary	Change in sedentary leisure time	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 sedentary leisure time per day. Participants will indicate which hours represent leisure time during workdays and off days/weekends to allow us to ascertain this outcome.	Baseline, 6 weeks, 12 weeks
Secondary	Change in self-reported physical activity	The International Physical Activity Questionnaire (IPAQ) is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of MET-minutes of moderate or greater activity per week, and change will be assessed by subtracting the baseline score from the 6- and 12-week scores.	Baseline, 6 weeks, 12 weeks
Secondary	Change in positive affect (positive affect items of the Positive and Negative Affect Schedule [PANAS])	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 6 and 12 weeks. Higher scores indicate higher levels of positive affect.	Baseline, 6 weeks, 12 weeks
Secondary	Change in optimism (Life Orientation Test - Revised [LOT-R])	The 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 6 and 12 weeks. Higher scores indicate higher levels of optimism.	Baseline, 6 weeks, 12 weeks
Secondary	Change in life satisfaction (Satisfaction with Life Scale [SWLS])	The Satisfaction with Life Scale is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (Range: 5-35). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.	Baseline, 6 weeks, 12 weeks
Secondary	Change in depressive symptoms (Hospital Anxiety and Depression Scale depression subscale [HADS-D])	The Hospital Anxiety and Depression Scale depression subscale (HADS-D) 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 6 and 12 weeks. Higher scores indicate higher levels of depression.	Baseline, 6 weeks, 12 weeks
Secondary	Change in anxiety (Hospital Anxiety and Depression Scale anxiety subscale [HADS-A])	The Hospital Anxiety and Depression Scale (HADS)-anxiety 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 6 and 12 weeks. Higher scores indicate higher levels of anxiety.	Baseline, 6 weeks, 12 weeks
Secondary	Change in exercise self-efficacy (Self-efficacy for Exercise Scale [SES])	The Self-efficacy for Exercise Scale will be used to measure exercise self-efficacy. This is a 9-item scale used to assess an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 20+ minutes per session in the future. (Range: 0-90). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of self-efficacy.	Baseline, 6 weeks, 12 weeks
Secondary	Change in social support (Norbeck Social Support Questionnaire)	The Norbeck Social Support Questionnaire will be used to assess an individual's perceived emotional and tangible support. Likert scale ratings for each person in the individual's social network will be made and the average across the social network will be calculated (Range:0-4). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of perceived social support.	Baseline, 6 weeks, 12 weeks
Secondary	Change in perceived constraints (perceived constraints subscale of the MIDUS Sense of Control measure)	The 8-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - perceived constraints (Range: 8-56). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of perceived constraints.	Baseline, 6 weeks, 12 weeks
Secondary	Change in personal mastery (personal mastery subscale of the MIDUS Sense of Control measure)	The 4-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - perceived constraints (Range: 4-28). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate higher levels of perceived constraints.	Baseline, 6 weeks, 12 weeks
Secondary	Change in function (General Health Questionnaire-12 [GHQ-12])	The General Health Questionnaire-12 consists of 12 items and assesses function (Range: 0-36). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate worse functional status.	Baseline, 6 weeks, 12 weeks
Secondary	Change in mental health related quality of life (Medical Outcomes Study Short Form-12 mental component score [SF-12 MCS])	Mental health related quality of life will be assessed via the mental component score of the Medical Outcomes Study SF-12 (Range: 0-100). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate better health-related quality of life.	Baseline, 6 weeks, 12 weeks
Secondary	Change in physical health related quality of life (Medical Outcomes Study Short Form-12 physical component score [SF-12 PCS])	Physical health related quality of life will be assessed via the physical component score of the Medical Outcomes Study SF-12 (Range: 0-100). Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks. Higher scores indicate better health-related quality of life.	Baseline, 6 weeks, 12 weeks
Secondary	Change in body weight	Body weight (in kilograms) will be measured by nurses. Change will be calculated by subtracting the weight at baseline from the weight at 6 and 12 weeks.	Baseline, 6 weeks, 12 weeks
Secondary	Change in body mass index (in kilograms per square meter)	Height and weight will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.	Baseline, 6 weeks, 12 weeks
Secondary	Change in waist circumference (in centimeters)	Waist circumference will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.	Baseline, 6 weeks, 12 weeks
Secondary	Change in blood pressure (millimeters of mercury)	Blood pressure will be measured by nurses at baseline, 6, and 12 weeks. Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.	Baseline, 6 weeks, 12 weeks