Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AG070161 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAP to Health | Behavioral | 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Hooker, PhD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Institute | Bloomington | Minnesota | 55425 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MAP to Health Intervention: Phase 2 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Testing | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
Study period: 12 weeks
This study did not impose a physical activity plan, rather it encourage free choice of activities. As with any physical activity, there is a slight risk that participants could get injured during the study, but this trial was defined as a low risk study thus no adverse event/or serious adverse events were defined in the study protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MAP to Health Intervention: Phase 2 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Hooker, PhD, MPH | HealthPartners Institute | 952-967-5056 | stephanie.a.hooker@healthpartners.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 21, 2022 | Aug 24, 2023 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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). A higher score indicates a greater sense of needs satisfaction, a better outcome. Items are averaged within and across the subscales for total scores. | This study used a double baseline pilot trial design. Participants completed a pre-test assessment (-4 weeks) at which time demographics were gathered for N=35 participants, defining the overall population. Four weeks later, participants completed a baseline assessment (time 0) which included N=34 participants, the start of the intervention. | Mean | Standard Deviation | score on a scale |
|
| 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). 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. | This study used a double baseline pilot trial design. Participants completed a pre-test assessment (-4 weeks) at which time demographics were gathered for N=35 participants, defining the overall population. Four weeks later, participants completed a baseline assessment (time 0) which included N=34 participants, the start of the intervention. | Mean | Standard Deviation | score on a scale |
|
| Autonomous Motivation | Autonomous motivation was measured using the Behavioral Regulations in Exercise Questionnaire, version 4. Three subscales (intrinsic, integrated, and identified) with 4 items each assess autonomous motivations for exercise on the self-determination theory continuum. Items are summed within each subscale (range, 4-28) and then subscale scores are averaged for an autonomous motivation scale, (range 4-28). Higher scores on the autonomous subscale indicate greater internalized motivation, a positive outcome. | This study used a double baseline pilot trial design. Participants completed a pre-test assessment (-4 weeks) at which time demographics were gathered for N=35 participants, defining the overall population. Four weeks later, participants completed a baseline assessment (time 0) which included N=34 participants, the start of the intervention. | Mean | Standard Deviation | score on a scale |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | After enrollment of 35 study participants, one participant withdrew and one was lost to follow-up. | Posted | Median | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | within 1 week post-intervention |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|