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

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HealthPartners Institute

Status

Completed

Conditions

Physical Inactivity

Treatments

Behavioral: MAP to Health

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05332145
R21AG070161 (U.S. NIH Grant/Contract)
A20-287

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

40 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Intervention development and testing
Experimental group
Description:
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.
Treatment:
Behavioral: MAP to Health

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Amy LaFrance, MPH; Jule Muegge, MPH

Data sourced from clinicaltrials.gov

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