Planning Actions for Consistent Engagement

NCT07447401 | Not Yet Recruiting

• 1 other identifier: IRB-FY25-380
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Does greater consistency and successful enactment of action plans result in more substantial changes in PA habits, behavior, and cognitive functioning?
3. 3.Non-PA planning (generic weekly planning)
4. 4.PA planning (weekly planning for PA)
5. 5.PA trial-and-error planning (weekly PA plans followed by preferred plan adoption)
6. 6.Wear Fitbit monitors continuously for 9 months to track PA behavior
7. 7.Complete mobile cognitive assessments daily for 7 days before the intervention, monthly during the intervention, and at follow-up
8. 8.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

Keywords

Action Planning; Physical Activity; Cognition; Habit; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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)

  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 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 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

  The single item will be administered baseline, weekly during the 6-month intervention, and at the end of the 3-month follow-up.

Study Arms (3)

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.

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.

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.

Behavioral: Non-PA Action Planning

Interventions

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.

Non-physical activity planning group

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.

Physical activity planning group; Physical activity trial and error planning group

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.

Physical activity trial and error planning group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Greensboro: lead
• University of South Carolina: collaborator

Study Sites (1)

University of North Carolina Greensboro

Greensboro, North Carolina, 27412, United States

Location

MeSH Terms

Conditions

Motor Activity; Habits

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Jaclyn Maher

CONTACT

336-256-1379; jpmaher@uncg.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)