Physical InactivityMAPNCT05332145
MAP to Health Pilot Study: A Physical Activity Intervention for Midlife Adults
A study testing MAP to Health in people with Physical Inactivity, run by HealthPartners Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- MAP to Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 4 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Institute
Bloomington, Minnesota, 55425
About this study
Official title: 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.
- Conditions
- Physical Inactivity
- Being tested
- MAP to Health
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP to HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention development and testing | Experimental | 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. Receives: Behavioral: MAP to Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start4 Nov 2022
- Primary completion3 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In Phase 1, the investigators will develop the MAP to Health web-based interview that will be used to explore what is particularly meaningful to participants, how physical activity is consistent with those goals, and what activities patients plan to engage in. Participants (N=12) will complete the interview and rate the ease of use, usefulness, intention to use, and theoretical fidelity of the intervention. In Phase 2, the investigators will conduct a proof-of-concept pilot trial using a double-pretest single group design. Participants (N=35) 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stephanie Hooker, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332145
- Sponsor's protocol ID
- A20-287
- Other IDs
- R21AG070161
- Acronym
- MAP
- Status last verified
- Jun 2023
- First submitted
- 4 Apr 2022
- Last updated
- 6 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Proof-of-Concept Trial of a Meaning- and Theory-based Physical Activity Intervention
- ClinicalTrials.gov ID
- NCT05332145
- Acronym / sponsor ID
- MAP / A20-287
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Posted 6 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In Phase 1, the investigators will develop the MAP to Health web-based interview that will be used to explore what is particularly meaningful to participants, how physical activity is consistent with those goals, and what activities patients plan to engage in. Participants (N=12) will complete the interview and rate the ease of use, usefulness, intention to use, and theoretical fidelity of the intervention. In Phase 2, the investigators will conduct a proof-of-concept pilot trial using a double-pretest single group design. Participants (N=35) 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention development and testing | Experimental | Behavioral: MAP to HealthPhase 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. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAP to HealthIn 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. | Behavioural | Intervention development and testing |
Primary outcome
Meaning Salience
Time frame: 12 weeks
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.
Basic Psychological Needs Satisfaction
Time frame: 12 weeks
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.
Autonomous Motivation
Time frame: 12 weeks
• 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.
Technology Acceptance
Time frame: within 1 week post-intervention
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Hooker, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAP to Health in people with Physical Inactivity, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meaning Salience (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.