Planning Actions for Consistent Engagement

NCT07447401 — Not applicable, Not yet recruiting, 148 participants, University of North Carolina, Greensboro

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Manipulating Action Plans to Improve Physical Activity Behavior and Cognitive Health in Older Adults

Registry	NCT07447401, acronym PACE
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	148 (Estimated)
Sponsor	University of North Carolina, Greensboro (Other); collaborators: University of South Carolina
Conditions	Physical Activity, Cognition, Habits
Interventions	Non-PA Action Planning, PA Action Planning, Consistency in Action Plans (Behavioral)
Dates	start 2027-01-01 (estimated), primary completion 2028-07-01 (estimated), completion 2028-07-01 (estimated), first posted 2026-03-03, last updated 2026-03-11
Locations	1 site in United States

-Summary

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:

1. 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?
2. 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.:

1. Non-PA planning (generic weekly planning)
2. PA planning (weekly planning for PA)
3. PA trial-and-error planning (weekly PA plans followed by preferred plan adoption)

Participants will:

1. Wear Fitbit monitors continuously for 9 months to track PA behavior
2. Complete mobile cognitive assessments daily for 7 days before the intervention, monthly during the intervention, and at follow-up
3. Create action plans and report on PA habits, intentions, and plan enactment weekly during the intervention and at follow-up

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+Arms and interventions

Arm	Type	Interventions	Description
Physical activity trial and error planning group	Experimental	Behavioral: PA Action Planning; Behavioral: Consistency in Action Plans	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.
Physical activity planning group	Active comparator	Behavioral: PA Action Planning	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.
Non-physical activity planning group	Placebo comparator	Behavioral: Non-PA Action Planning	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.

Non-PA Action Planning (Behavioral): 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.
PA Action Planning (Behavioral): 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.
Consistency in Action Plans (Behavioral): 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.

+Outcome measures

Primary outcomes

Change in Device-Based Physical Activity from Baseline to 6 Months [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.]: The wrist-worn Fitbit Inspire will provide an device-based measure of minutes/day of moderate-to-vigorous physical activity (based on step cadence)

Secondary outcomes

Change in Grid Memory Task Performance from Baseline to 6 Months [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.
Change in Symbol Search Task Performance from Baseline to 6 Months [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.]: 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.
Change in Physical Activity Habit Strength from Baseline to 6 Months [The single item will be administered baseline, weekly during the 6-month intervention, and at the end of the 3-month follow-up.]: 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.

+Eligibility

Sex: All, ages: 60 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of North Carolina Greensboro	Greensboro, North Carolina	United States

+Study documents

Informed Consent Form (PDF, 2026-02-23)