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

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Inactivity
• Intervention / Treatment: Behavioral: MAP to Health

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartners Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention development and testing; Phase 1 participants (N=12) will complete the MAP to Health online interview and rate the ease of use, usefulness, intention to use, and theoretical fidelity of the intervention. Phase 2 participants (N=35) will participate in a proof-of-concept pilot trial via a double-pretest single group design. 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 week period.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basic need satisfaction (Psychological Needs Satisfaction in Exercise Scale)	Basic needs satisfaction is a primary outcome for Aim 2. The Psychological Needs Satisfaction in Exercise Scale (PNSE) will be used to measure satisfaction of needs of autonomy (e.g., "I feel free to exercise in my own way"), competence (e.g., "I feel confident in my ability to perform exercises that personally challenge me"), and relatedness (e.g., "I feel attached to my exercise companions because they accept me for who I am") in exercise contexts. The PNSE has 18-items that participants rate on a 6-point Likert-type scale ranging from 1 (false) to 6 (true). Items are averaged within and across the subscales for total scores. Previous research has demonstrated that the PNES has strong internal consistency reliability (αs ≥ .90), construct validity, and convergent validity. Participants will complete this measure at 4-week intervals (pretest -4, baseline 0, midpoint 4, posttest 8) over the course of 12 weeks.	12 weeks
Autonomous motivation (Behavioral Regulations in Exercise Questionnaire - 4; BREQ-4)	Motivation internalization will be measured using the Behavioral Regulations in Exercise Questionnaire, version 4 (BREQ-4). The 28-item BREQ-4 assesses motivations for exercise on the self-determination theory continuum. There are 7 subscales with 4 items each: amotivation, external regulation, introjected regulation-avoidance, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. The subscales will be combined using a bifurcation approach and scored into two subscales: autonomous and controlled motivation. Participants will complete this measure at 4-week intervals (pretest -4, baseline 0, midpoint 4, posttest 8) over the course of 12 weeks.	12 weeks

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Stephanie Hooker, PhD, HealthPartners Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A20-287; R21AG070161 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If approved by HealthPartners Office for Compliance and Integrity and the HealthPartners Institutional Review Board, the investigators will also follow our local standard operating procedures for data de-identification at the conclusion of the study and provide de-identified datasets to National Institute on Aging and posted on a generalist data repository (e.g., Open Science Framework) in a preferred format. Datasets will also be provided to other qualified researchers at written request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No