- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447401
Planning Actions for Consistent Engagement (PACE)
Manipulating Action Plans to Improve Physical Activity Behavior and Cognitive Health in Older Adults
The goal of this clinical trial is to evaluate whether different approaches to action planning can promote physical activity (PA) habits, increase PA behavior, and improve cognitive functioning in older adults who are currently inactive or insufficiently active.
The main questions it aims to answer are:
- Does a trial-and-error approach to PA action planning lead to greater improvements in PA habits, PA behavior, and cognitive functioning compared to standard PA planning or non-PA planning?
- Does greater consistency and successful enactment of action plans result in more substantial changes in PA habits, behavior, and cognitive functioning?
Researchers will compare three groups to determine which planning approach yields superior outcomes.:
- Non-PA planning (generic weekly planning)
- PA planning (weekly planning for PA)
- PA trial-and-error planning (weekly PA plans followed by preferred plan adoption)
Participants will:
- Wear Fitbit monitors continuously for 9 months to track PA behavior
- Complete mobile cognitive assessments daily for 7 days before the intervention, monthly during the intervention, and at follow-up
- Create action plans and report on PA habits, intentions, and plan enactment weekly during the intervention and at follow-up
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaclyn Maher
- Phone Number: 336-256-1379
- Email: jpmaher@uncg.edu
Study Locations
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North Carolina
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Greensboro, North Carolina, United States, 27412
- University of North Carolina Greensboro
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Contact:
- Jaclyn Maher
- Phone Number: 336-256-1379
- Email: jpmaher@uncg.edu
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Principal Investigator:
- Jaclyn Maher
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 60 years or older
- own a smartphone
- willingness to download an app onto their personal smartphone and complete the cognitive assessments and questionnaires on their smartphone, wear the accelerometer, and undergo randomization
- insufficient PA (i.e., not meeting current PA guidelines) but report intentions to increase their PA over the next 6 months
- self-reported ability to ambulate without assistance
- English as a primary language
Exclusion Criteria:
- Individuals that are unwilling or unable to obtain medical clearance (if needed)
- have received a diagnosis of mild cognitive impairment or ADRD
- concurrently participating in another study involving PA or weight loss
- planning to have surgery or relocate within the next 9 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical activity trial and error planning group
Participants in this group will be instructed to create weekly action plans to engage in physical activity.
Participants in this condition will be advised to spend 6 weeks trying different action plans each week to see what works best for them and then sticking to their preferred plan for the remaining weeks so their brain can 'learn' these mental cue-behavior associations that underpin habits.
Further, participants in this group will be informed of the recommended volume of physical activity based on federal guidelines and instructed to develop action plans to engage in a self-selected physical activity (consistent with low-to-moderate intensity physical activity) that progressively increase in intensity and duration during the 6-month intervention.
Participants in this group will receive weekly prompts and reminders to create action plans on their smartphone.
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Participants will create weekly action plans to engage in physical activity.
Action plans will include specifying when, where, how, with whom participants will engage in physical activity over the upcoming week.
Participants will be given six weeks to experiment with different physical activity action plans (changing the contextual features of the plan).
In the seventh week, participants will be encouraged to stick with their best plan for the remaining weeks of the intervention.
By maintaining the same plan over the remaining weeks of the intervention, this should promote context stability of the planned behavior.
|
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Active Comparator: Physical activity planning group
Participants in this group will be instructed to create weekly action plans to engage in physical activity.
Further, participants in this group will be informed of the recommended volume of physical activity based on federal guidelines and instructed to develop action plans to engage in a self-selected physical activity (consistent with low-to-moderate intensity physical activity) that progressively increase in intensity and duration during the 6-month intervention.
Participants in this group will receive weekly prompts and reminders to create action plans on their smartphone.
|
Participants will create weekly action plans to engage in physical activity.
Action plans will include specifying when, where, how, with whom participants will engage in physical activity over the upcoming week.
|
|
Placebo Comparator: Non-physical activity planning group
The non-physical activity planning group is our control condition, accounting for social contact and attention.
Participants in this group will be instructed to create weekly action plans for one of four target health behavior (i.e., practice good sleep hygiene, make healthy food choices, wash my hands, practice good oral hygiene).
Participants in this group will receive weekly prompts and reminders to create action plans on their smartphone.
|
Participants will create weekly action plans to engage in one of four non-PA health behaviors (i.e., practice good sleep hygiene, make healthy food choices, wash my hands, practice good oral hygiene).
Action plans will include specifying when, where, how, with whom participants will engage in the target behavior over the upcoming week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Device-Based Physical Activity from Baseline to 6 Months
Time Frame: Device-based physical activity will be assessed daily during the 7-day baseline, daily during the 6-month intervention, and daily during the 3-month follow-up period.
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The wrist-worn Fitbit Inspire will provide an device-based measure of minutes/day of moderate-to-vigorous physical activity (based on step cadence)
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Device-based physical activity will be assessed daily during the 7-day baseline, daily during the 6-month intervention, and daily during the 3-month follow-up period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Grid Memory Task Performance from Baseline to 6 Months
Time Frame: The Grid Memory Task will be administered for 7 consecutive days at baseline, for 7 days each month during the 6 month intervention, and for 7 days at the end of the 3-month follow-up.
|
The Grid Memory Task from the Mobile Monitoring of Cognitive Change Toolkit will be administered through participants' smartphone for 7 consecutive days (with morning and evening assessments) at each timepoint and measures working memory.
The primary outcome for Grid Memory Task is the Euclidean distance of the red dots between study and recall arrays.
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The Grid Memory Task will be administered for 7 consecutive days at baseline, for 7 days each month during the 6 month intervention, and for 7 days at the end of the 3-month follow-up.
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Change in Symbol Search Task Performance from Baseline to 6 Months
Time Frame: The Search Symbol Task will be administered for 7 consecutive days at baseline, for 7 days each month during the 6 month intervention, and for 7 days at the end of the 3-month follow-up.
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The Search Symbol Task from the Mobile Monitoring of Cognitive Change Toolkit will be administered through participants' smartphone for 7 consecutive days (with morning and evening assessments) at each timepoint and measures processing speed.
The primary outcome of Search Symbol Task is the median response time for accurate trials.
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The Search Symbol Task will be administered for 7 consecutive days at baseline, for 7 days each month during the 6 month intervention, and for 7 days at the end of the 3-month follow-up.
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Change in Physical Activity Habit Strength from Baseline to 6 Months
Time Frame: The single item will be administered baseline, weekly during the 6-month intervention, and at the end of the 3-month follow-up.
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A single item from the Self-Reported Behavioural Automaticity Index (i.e., "Being physically active is something I do automatically.")
will be administered weekly on participants' smartphone and measures physical activity habit strength.
Participants will respond on a 7-point Likert scale with higher values indicating stronger habit strength.
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The single item will be administered baseline, weekly during the 6-month intervention, and at the end of the 3-month follow-up.
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY25-380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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