Physical ActivityPACENCT07447401
Planning Actions for Consistent Engagement
A study testing Non-PA Action Planning, PA Action Planning and Consistency in Action Plans in people with Physical Activity and Cognition, run by University of North Carolina, Greensboro at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Cognition, Habits
- What is being tested?
- Non-PA Action Planning, PA Action Planning and Consistency in Action Plans
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina Greensboro
Greensboro, North Carolina, 27412
Jaclyn Maher, 336-256-1379, jpmaher@uncg.edu
Jaclyn Maher
About this study
Official title: 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:
Read more
- 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
- Conditions
- Physical Activity, Cognition, Habits
- Being tested
- Non-PA Action Planning, PA Action Planning, Consistency in Action Plans
- Keywords
- Action Planning, Physical Activity, Cognition, Habit, Older Adults
- Medical subject headings
- Motor Activity, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-PA Action PlanningBehavioural
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 PlanningBehavioural
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 PlansBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity trial and error planning group | Experimental | 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. Receives: Behavioral: PA Action Planning; Behavioral: Consistency in Action Plans |
| Physical activity planning group | Active comparator | 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. Receives: Behavioral: PA Action Planning |
| Non-physical activity planning group | Placebo comparator | 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. Receives: Behavioral: Non-PA Action Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Device-Based Physical Activity from Baseline to 6 Months
The wrist-worn Fitbit Inspire will provide an device-based measure of minutes/day of moderate-to-vigorous physical activity (based on step cadence)
Measured: 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.
Secondary outcomes (3)
Change in Grid Memory Task Performance from Baseline to 6 Months
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.
Measured: 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.
Change in Symbol Search Task Performance from Baseline to 6 Months
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.
Measured: 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.
Change in Physical Activity Habit Strength from Baseline to 6 Months
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.
Measured: The single item will be administered baseline, weekly during the 6-month intervention, and at the end of the 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447401
- Sponsor's protocol ID
- IRB-FY25-380
- Acronym
- PACE
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulating Action Plans to Improve Physical Activity Behavior and Cognitive Health in Older Adults
- ClinicalTrials.gov ID
- NCT07447401
- Acronym / sponsor ID
- PACE / IRB-FY25-380
- Conditions
- Physical Activity, Cognition, Habits
- Keywords
- Action Planning, Physical Activity, Cognition, Habit, Older Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Collaborators
- University of South Carolina
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity trial and error planning group | Experimental | Behavioral: PA Action Planning, Behavioral: Consistency in Action PlansParticipants 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 PlanningParticipants 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 PlanningThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-PA Action PlanningParticipants 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. | Behavioural | Non-physical activity planning group |
| PA Action PlanningParticipants 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. | Behavioural | Physical activity planning group, Physical activity trial and error planning group |
| Consistency in Action PlansParticipants 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. | Behavioural | Physical activity trial and error planning group |
Primary outcome
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)
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-PA Action Planning, PA Action Planning and Consistency in Action Plans in people with Physical Activity and Cognition, run by University of North Carolina, Greensboro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaclyn Maher (336-256-1379, jpmaher@uncg.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.