Planning Actions for Consistent Engagement

Официальное название

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

Обзор

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

Вмешательства

• Поведенческое Non-PA Action Planning
  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.
• Поведенческое PA Action Planning
  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.
• Поведенческое Consistency in Action Plans
  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.

Первичные конечные точки

• Change in Device-Based Physical Activity from Baseline to 6 Months [Срок оценки: 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.]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of North Carolina Greensboro — Greensboro

Идентификаторы

NCT: NCT07447401 · IRB-FY25-380

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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