Trial Outcomes & Findings for MAP to Health Pilot Study: A Physical Activity Intervention for Midlife Adults (NCT NCT05332145)

Last Updated: 2023-12-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Testing n=35 Participants 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.
Age, Categorical <=18 years	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=35 Participants
Sex: Female, Male Female	27 Participants n=35 Participants
Sex: Female, Male Male	8 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=35 Participants
Race (NIH/OMB) Asian	7 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	3 Participants n=35 Participants
Race (NIH/OMB) White	23 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=35 Participants
Basic Psychological Needs Satisfaction Competence	4.3 score on a scale STANDARD_DEVIATION 1.27 • n=34 Participants • 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.
Basic Psychological Needs Satisfaction Autonomy	5.2 score on a scale STANDARD_DEVIATION 0.77 • n=34 Participants • 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.
Basic Psychological Needs Satisfaction Relatedness	3.7 score on a scale STANDARD_DEVIATION 1.49 • n=34 Participants • 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.
Meaning Salience	5.09 score on a scale STANDARD_DEVIATION 1.48 • n=34 Participants • 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.
Autonomous Motivation	19.78 score on a scale STANDARD_DEVIATION 5.5 • n=34 Participants • 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.

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	MAP to Health Intervention: Phase 2 n=33 Participants 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.
Meaning Salience	5.61 score on a scale Standard Deviation 1.22

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MAP to Health Intervention: Phase 2 n=33 Participants 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.
Basic Psychological Needs Satisfaction Competence	5.0 score on a scale Standard Deviation 0.86
Basic Psychological Needs Satisfaction Autonomy	5.7 score on a scale Standard Deviation 0.6
Basic Psychological Needs Satisfaction Relatedness	4.3 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 12 weeks

Population: After enrollment of 35 study participants, one participant withdrew and one was lost to follow-up.

• 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.

Outcome measures

Outcome measures
Measure	MAP to Health Intervention: Phase 2 n=33 Participants 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.
Autonomous Motivation	21.43 score on a scale Standard Deviation 5.06

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MAP to Health Intervention: Phase 2 n=32 Participants 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.
Technology Acceptance Usability	4.28 score on a scale Standard Deviation 0.64
Technology Acceptance Ease of Use	4.32 score on a scale Standard Deviation 0.76
Technology Acceptance Intent to Use	3.77 score on a scale Standard Deviation 1.29

Adverse Events

MAP to Health Intervention: Phase 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Hooker, PhD, MPH

HealthPartners Institute

Phone: 952-967-5056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place