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NCT Number: NCT07447401

Planning Actions for Consistent Engagement

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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Key information

Conditions

Physical Activity Behavior Cognition Habits Motor Activity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Greensboro

Greensboro, North Carolina, 27412, United States

Location contact

Jaclyn Maher

CONTACT

[email protected]

336-256-1379

Jaclyn Maher

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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

  1. 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.

  2. 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.

    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.

  3. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaclyn Maher

CONTACT

[email protected]

336-256-1379

Sponsors and collaborators

Lead sponsor

University of North Carolina, Greensboro

Other

Collaborators

  • University of South Carolina

Registry information

Official study title

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

Acronym: PACE

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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