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临床试验/NCT07447401
NCT07447401尚未招募不适用

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

University of North Carolina, Greensboro1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2027年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
148
试验地点
1
主要终点
Change in Device-Based Physical Activity from Baseline to 6 Months

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: PA Action Planning (Behavioral)

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.

干预措施: Consistency in Action Plans (Behavioral)

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.

干预措施: PA Action Planning (Behavioral)

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.

干预措施: Non-PA Action Planning (Behavioral)

结局指标

主要结局

Change in Device-Based Physical Activity from Baseline to 6 Months

时间窗: 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)

次要结局

  • 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.)

研究者

发起方
University of North Carolina, Greensboro
申办方类型
Other
责任方
Sponsor

研究点 (1)

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