MAP to Health Pilot Study: A Physical Activity Intervention for Midlife Adults

Physical Inactivity Clinical Trial

— MAP  

Official title:

Development and Proof-of-Concept Trial of a Meaning- and Theory-based Physical Activity Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332145
• Other study ID #: A20-287
• Secondary ID: R21AG070161
• Status: Completed
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: May 4, 2023

Study information

• Verified date: June 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study has two aims: (1) to develop and examine the acceptability of the technological and theoretical frameworks of MAP to Health and (2) to determine whether MAP to Health is related to changes in theoretically identified mechanisms of behavior change (meaning salience, basic psychological needs satisfaction, and internal motivation). In an exploratory aim, the study will assess how the intervention and mechanisms of change are related to changes in physical activity. Participants will be adults in midlife (ages 40-64) who are insufficiently active, are interested in increasing physical activity, do not have contraindications to engaging in physical activity, and are patients in a large healthcare system in the Midwest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 4, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

Inclusion Criteria:

• Midlife (ages 40-64 at enrollment)
• Able to read and understand English
• Insufficiently active (engaging in =10 and =90 min of physical activity/week)
• Intention to increase physical activity in the next 30 days
• Has consistent access to a phone with text-messaging capability

Exclusion Criteria:

• Greater than minimal risk to starting a physical activity program (Physical Activity Readiness Questionnaire score > 0)
• Body Mass Index (BMI)= 40
• Currently pregnant
• Has opted out of research
• Diagnosis of metastatic cancer or cardiovascular disease
• Residing in a nursing home or long-term care facility
• Cognitive or psychiatric conditions that preclude completion of questionnaires, including dementia diagnosis
• Diagnosis of severe psychiatric disorder (e.g., Bipolar Disorder, Schizophrenia)
• Diagnosis of substance use disorder or AUDIT-C62 >3 for women or >4 for men

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• MAP to Health
In Phase 1, participants will complete the web-based interview and Aim 1 measures, assessing acceptability and usability of the intervention. The investigators will review whether the intervention appropriately gathers information needed to program theory-based, personalized text messages. After completing the measures, a list of text messages for that participant will be generated and sent to the participant for review. Participants will review the text messages and rate the extent to which the messages are personalized. In Phase 2, the investigators will conduct a proof-of-concept pilot trial in which participants will complete a 4-week pretest monitoring period and an 8-week pilot trial of the intervention, with assessments of Self-Determination Theory mechanisms and meaning salience at pretest (-4 weeks), baseline (0 weeks), midpoint (4 weeks) and posttest (8 weeks). In addition, participants will wear accelerometers to assess physical activity during the 12 weeks.

Locations

Country	Name	City	State
United States	HealthPartners Institute	Bloomington	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meaning Salience	The Meaning Awareness Scale is a 6-item self-report measure that assesses meaning salience. Participants rate the extent to which they were aware of meaning over the past day (e.g, "I was aware of the meaning in my life" on a 7-point Likert type scale ranging from 1 (rarely) to 7 (very often). Items are averaged for a total score (range, 1-7). Participants complete the scale on three random days during each of the four assessment periods and total scores are averaged across those three days. A higher score signifies greater meaning salience, a better outcome.	12 weeks
Primary	Basic Psychological Needs Satisfaction	The Psychological Needs Satisfaction in Exercise Scale is a self-report measure used to assess participants' satisfaction of three basic psychological needs (autonomy, competence, and relatedness) in exercise. The scale has 18 items that participants rate on a 6-point Likert-type scale ranging from 1 (false) to 6 (true). Items are averaged within each subscale (autonomy, competence, and relatedness) with possible scores ranging from 1-6. Higher scores indicate greater satisfaction of autonomy, competence and relatedness, a better outcome.	12 weeks
Primary	Autonomous Motivation	• Autonomous motivation was measured using the Behavioral Regulations in Exercise Questionnaire, version 4. The 28-item self-report measure assesses motivations for exercise on the self-determination theory continuum. There are 7 subscales with 4 items each (intrinsic, integrated, identified, introjected - approach, introjected - avoidance, external, and amotivation). Items are summed within each subscale (total score range, 4-28). The subscales were combined using a bifurcation approach, where subscale scores were averaged into two subscales: autonomous (intrinsic, integrated, and identified, total score range 4-28) and controlled motivation (introjected-approach, introjected - avoidance, and external, total score range, 4-28). Higher scores on the autonomous subscale indicate greater internalized motivation, a positive outcome, whereas higher scores on the controlled subscale indicates greater external motivation, a negative outcome.	12 weeks
Primary	Technology Acceptance	Participants answered 10 questions rating the extent to which they found the MAP to Health intervention easy to use (4 items) and useful (4-items) and their intentions to use the intervention in the future (2 items). Survey questions were based on previous research and modified for the purposes of this study. Participants rated each item on a scale from 1 (strongly disagree) to 5 (strongly agree). Items were averaged within each subscale, with possible total scores ranging from 1-5. A higher score represents greater technology acceptance, a better outcome.	within 1 week post-intervention