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

NCT ID: NCT05332145

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2023-05-04

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.

Conditions

Physical Inactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention development and testing

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.

Group Type: EXPERIMENTAL

MAP to Health

Intervention Type: 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.

Interventions

MAP to Health

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Hooker, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

HealthPartners Institute

Bloomington, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R21AG070161

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A20-287

Identifier Type: -

Identifier Source: org_study_id