Planning Actions for Consistent Engagement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of North Carolina, Greensboro
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Non-PA Action Planning
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
148 Participants
are divided into 3 treatment groupsGroup A: Physical activity trial and error planning groupExperimental treatment 2 interventions
Group B: Physical activity planning groupActive comparator 1 intervention
Group C: Non-physical activity planning groupPlacebo comparator 1 intervention
Trial outcomes
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)
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.Secondary outcomes
1
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.
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.2
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.
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.3
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Greensboro
Lead sponsor
University of South Carolina
Collaborator
Source ClinicalTrials.gov
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