Clinical trial NCT05332145: MAP to Health Pilot Study: A Physical Activity Intervention for Midlife Adults
Official title: Development and Proof-of-Concept Trial of a Meaning- and Theory-based Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-04-18
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Meaning Salience
timeFrame: 12 weeks
measure: Basic Psychological Needs Satisfaction
timeFrame: 12 weeks
measure: Autonomous Motivation
timeFrame: 12 weeks
measure: Technology Acceptance
timeFrame: within 1 week post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners Institute
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Stephanie Hooker, PhD
role: PRINCIPAL_INVESTIGATOR
References: